Questions? Records Contact processed FDA/CDRH/OCE/DID ... · This letter refers to my letter of...

Records processed under FOIA 2018-2770, Released by CDRH on 7/18/2018Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA 2018-2770, Released by CDRH on 7/18/2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

5io(k)# U Y J O ^ J / X

FOI - 510(k) Search

/ / Enclosed is referenced 510(k), No decision W letter issued (in process). Still within 90 day period. Due Date

/ / Enclosed is referenced 5lO(k). Decision letter NR issued. /_/ Substantially Equivalent (FA).

/_/ Non Substantially Equivalent (FR).

f j No Decision (FD).

Still within 90 day period. Due Date

/_/ Enclosed is referenced 510(k). No decision NR letter issued. Past 90 day period,

Enclosed/fs referenced 510(k). Decision letter issue /_Vûbstantiany Equivalent (FA),


r j No Decision (FD).

Past 90 day period.

/_/ Enclosed is referenced 510(k). Decision letter NR issued. /_/ Substantially Equivalent (FA).


r j No Decision (FD).

Past 90 day period but within extension period. Due Date

II No Record of Any Documents



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DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE ^ FOOD AND DRUG ADMINISTRATION

SILVERSPRING. MARYLAND 20SI0

fflAR] W 7

^ f ' f(760462A Jeffrey M. Kaufholz Electrical Shock Device 11725 Seventh Street East • • Treasure Island, Florida 33706

Dear Mr, Kaufholz;

Your Section 510(k) notification of intent to market the above device has Qe*eh" reviewed'and we have determined the device to be substantially equivalent to one marketed in interstate commerce prior "to May ?.8, 1975'i' the enactment date of the Medical Device Amendments of 1976. You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act until such time as your device or the type of device to which it is substantially equivalent has been classified under Section 513. At that time your device would be subject to additiional controls if it is classified into either class II (Standards) or class III (Premarket Approval).

General controls presently relate to annual registration and misbranding and adulteration provisions. In the near future the present general controls-vwi 11 be supplemented by additional regulations relating to current good manufacturing practices, records and reports, and others.

All regulatfoTTs'and information on meetings of the device classification panels, their recommendations, and the final decisions of the Agency will be published in the FEDERAL REGISTER as proposals. You should peruse this publication so that you can convey your views to the Agency if you so .desire, and so that you can promptly comply with any additional requirements subsequently imposed on your device. Subscriptions may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Such information also may be reviewed in the Office of the Hearing Clerk, FDA, 5500 Fishers Lane, Rockville, MD 20857.

This letter should not be construed as approval of your device or its labeling. If you desire comment as to'the status of the labeling for your drvice or any additional informat-ion pertaining to your responsibilities under the law, please contact the Division of Compliance, Bureau of Medical Devices and Diagnostic Products, 8757 Georgia Avenue, Silver Spring, MD 20910.

Sincerely yours.

k Yi David M. Link, Director Bureau of Medical Devices

and Diagnostic Products

FORM FLH 2973 <2/77)



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE _ . ' PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION SILVER SPRING, MARYLANO 20910

February .28, 1977

'P7

Section : 510(k) Number : K760462A Received: February 28, 1977 Product : Electrical Shock Device

Jeffrey M. Kaufholz 11725 7th St., East Treasure Island, FL 33706

Dear Mr. Kaufholz:

The information you have submitted as required by the above Section of the Federal Food, Drug, and Cosmetic Act for the referenced device has been received and assigned a unique document control nuifiber. Please cite this number in any future correspondence that relates to this submission.

We w.ill notify you when the processing of this submission has been completed or if any additional information is required, (]uestions concerning this submission should be directed to: V

Food and Drug Administration Bureau of Medical Devices and Diagnostic Products Document Control Center (HFK-2Q:) 8757 Georgia Avenue Silver Spring, MD 20910 (301) 427-7059

Sincerely yours,

Lisa A. De Maio Document Control Specialist Bureau of Medical Devices and Diagnostic Products

FORM FLH 297T (2/77)



, (

DEP/iRTMENT OF HEALTH. EDUCATION. AND WELFARE I PUBLIC HEALTH SERVICE

^ \ , FOOD ANO DRUG ADMINISTRATION

8757 Georgia Avenue Silver Spring, Maryland 20910

?

August 19, 1976

510(k) Submission

Electrical Shock Device Edward V. Kaufholz, Sr. • • Management Consultant P.O. Box 9581 Treasure Island, Florida 33740

Gentlemen:

The information you have submitted as required by Section 510(k) of the Federal Food, Drug, and Cosmetic Act for the referenced device has been received on August 18, 1976 and assigned document control number K760462 . Please reference this number in any future corrfeiôndence that refers to this submission.

We will notify you when the processing of this submission has been completed or if any additional information is required. Questions concerning this submission should be directed to:

Food and Drug Administration Bureau of Medical Devices and Diagnostic Products Document Control Center (HFK-20) 8757 Georgia Avenue Silver Spring, Maryland 20910 (301) 427-7172

Sincerely yours.

Robert W, Sauer Assistant Director for Program

Operations Bureau of Hedical Devices and Diagnostic Products



•'MEMORAXDU:\I DL?.\RT.MLNT OF HC.VLTM, EDUC.VTir^X, A\T) Wi.lJ vUl PUBLIC 1IF-.\LT11 SI.ilVlCK •:

FOOD .VN'D D:-VUG AD.\IINI.srR.\TION " " -

TO Eureiu Directcr Thrcjg.n: ?.z'z~rr, 5. Ker.nsdy, Ph.D.

Classification Cccrdinator

DATE:

FRONt

SL- y-CT 5;.:-(:<) lotificaticn .= n ^ i ^ o A l o ^ A

It is -y recc-TcfiCation that the subject 510(k) riotificaticn:

__X_i(A) Is substantially equivalent to irarkstsd devices

• • (B) Requires preniarket approval. NOT substantially equivalent to marketed devices (see data sheet)

(C) Does I'tOT require pra-arket approval. NOT substantially equivalent to -arketed devices but safety and effectiveness not a-factor in consideration

(D) Requires more data (ses data sheet)

(E) I s an Incomplete submission (see Sub.-ission sheet)

Additional Reviewer'.s Co--.ents

$ Q ^ / > 4 ^ ^ j 2 , ^ , . ^ ^ k ^ / / ^ Y t (k

/7%C<.^<I^QJ2^ • fJ7(^,^,yt..^,<iJ,^JL^^ 4^Y- . '

u

First Review:

Final Review;

Classificaiicn Coordinator

7 p bureau oireccci"

Date

\hm i 1977. Dace



B ' RECEIVED

^ D A / B / m p

" rFEBPB ^ / l : . j

CEHTER ^

Jeffrey M. Kaufholz 11725 Seventh Street East Treasure Island, Florida 33706 (813) 360-8827

February 21, 1977

Foo'd And Drug Administration Bureau of Medical Devices and Diagnistic Products / ) 8757 Georgia Avenue --Jfj^^^^-Zi^

ntrol r - f^l^mJt^^ Silver Spring, Maryland 20910

Ref: Document co

Gentlemen:

This letter refers to my letter of October 25, 1976, your reply November 2, 1976, and your subsequent phone calls to me requesting photographs.

Enclosed are two photognaphs, one showing the electrical Shock Device purchased from nherapy Department, St. Anthony Hospital, LouisvilT e7] KentucTTy. The other photograph shows the similar device I--propose to manufacture and sell.

The details of my device are contained in my letter to you dated October 25, 1976. This device will be labelled as follows:

Muscle Stimulator, Electric Shock maximum voltage, 67-1/2 Volts D.C. For use only as prescribed by a licensed physcian or physical therapist. Manufactured by: Capri Company Treasure Island, Florida 33706,

On the basis of similarity, I request FDA approval and classification as a Class I Device, as per Report No. 94-853, "Medical Device Amendments of 1976".

Please refer to my letter of October 25, 1976 for any further information.

Very truly yours,

^0\ 'y^^^Â^ fefTr^ M. Kailfhofz



3

Muscle stimulai^r, electric shock. Purchased from [Physical Therapy Department, St. Anthony Hospital, Loui svil 1 eT? Ky • Contains 67-1/2 Volt battery, potentiometer to vary voltage, and a push to impart electric shock pul.jes two skin contact pads.

button switch through



Muscle stimulator, electric shock. Upon FDA approval, to be manufactured and sold by Capri Company, Treasure Island, Florida 33706, Jeffrey M. Kaufholz, owner, This device will be labelled:

Muscle Stimulator, Electric Shock. Maximum voltage, 67-1/2 VolJ,s D.C. For use only as prescribed by a licensed physician or physical therapi St. Manufactured by; Capri Company Treasure Island, Florida 33706.



TO: Roberts. Kennedy, Ph.D. REVIEW — — O . Classification Coordinator RSK 'f

DML

DATE:

FROM:-

SUBJECT: 510 K Notification # L l U Y - ^ ^ .

Recommendation: • • " '

1. The 510 K Notification # is:

(A) .Substantially equivalent to the marketed devices '

(B) Premarket approval required. NOT substantially equivalent to the marketed devices (see the data sheet)

(C) Premarket approval NOT required, NOT substantially equivalent • .to the marketed devices but safety and effectiveness not a • factor in consideration. • " .

•j(^ (D) Requiring more data (see the data sheet) 'J ^ ' " • •

* . E) Incomplete Submission (see the Submission Sheet) . • • ' , • • ' f

• • - , 1 - - • •

2. Additional Reviewer's Comments:'



MEMORANDUM ?

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HE.ALTH SERVICE

FOOD AND DRUa ADMINISTRATION

TO File K760462 DATE: September 1, 1976

FROM : Johnsie W. Bailey (HFK-440)

SUBJECT: 510(k) Notification Number K760462

The information contained in this submission is insufficient for any type of determination. I telephoned Mr, Kaufholz, Management Consultant, to request additional data on this electrical shock device and also a device it may be substantially equivalent to.

Johnsie W. Bailey



lkî(,6^(o^

EDWAHD VINCENT KAUFHOLZ, SH. MANAGEMENT CaNSra.TANT

POST OFFICE BOX 9501

THEASUHE ISLAND, FLQHmA 3374D

(B13) 380-8087

August 16, 1976

Food and Drug Adminstration Bureau of Medical Cevices and Diagnostic Products Division of Compliance Registration and Device Listing (HFK-124) 8757 Georgia Avenue Silver Spring, Maryland 20910

"510(k) Notification'

Gentlemen:

It is the intention of my client to manufacture and sell an electrical shock device, maximum 57 1/2 Volts, used for muscle stimulation therapy. One such device has been used by one patient for fourteen months on an experimental basis and the doctors monitoring this case are pleased with the results. These doctors are now asking that more of these devices be made for other patients'use.

This will be a very small business, in fact a one man business, since there is only an extrememly limited market for the product.

If these devices are made only to a doctor's prescription, would that in any way eliminate the need for your approval?

Any help you can give us to get us thru this jungle of government gooble-dygook will be greatly appreciated!

Thank you.

ncerely yoirps'i'

Edward V. Kaufhol

EVK:m mmk . m. mwM m



2 ^/5 ^'^^ ^^'^^

Jeffrey M. Kaufholz 1172 5 Seventh Street East Treasure Island, Florida 3-3706

October 25, 1976

Food and Drug Administration ' T \ f k O . ¥"6 ?-* o ^ " ZQ Bureau of Medical Devices and Diagnostic Products g ^ Oj^ Division of Compliance c:> \ 7/\ ^ ^ Registration and Device Listing (HFK-12i|) g-^ \^ J^m 8 75 7 Georgia Avenue ^t^ ^.< Silver Spring I'laryland 20910 S o r i:rn

"510(k) Notification" o r\5 TJ

CJ -^

4=-Gentlemen:

I intend to manufacutre and market an electrical shock device used for muscle stimulation in cases of damaged nerves or paralysis in any limbs. The use of electrical muscle stimulation prevents muscle atrophy, and this is a standard therapy prescribed by physicians in such cases. For example, in a case of injury to an arm resulting in damaged and severed nerves which are repaired by nerve transplants, the regrowth of the repaired nerves will take many months. During this time muscle stimulation is necessary to prevent atrophy, since the patient can not voluntarily move the limb to exercise of stimulate the muscles. This is a necessary muscle therapy device.

The device I propose to manufacture and sell is very similar to a divice that has been sold by the j Physical Therapy Department of Saint Anthony Hospital, LouisvillenXentucky. That device has been prescribed by the renowned hand surgeon, Dr. Joseph E. Kutz, 250 East Liberty Street, Louisville, Kentucky M-0202. As a similar device, I suggest that my device could be classified as a Class I Device, as per Report No. 9M—853, "Medical Device Amendments of 19 36".

My muscle stimulator device is housed in a metal box measuring 5 1/4" X 3" X 2 1/8". Mounted into the top surface of this box is a push button switch and a potentiometer knob..: Two wire leads, each 3' long, extend from the box, terminating in metal_j cloth padded skin contact probes. Contained inside the.yboX is a 6 7-1/2 Volt battery, the voltage of which is varied by the potentiometer, and the momentary contact push button switch is used to impart the electrical pulses to the skin of the patient through the movable contact pads which are soaked in a saline solution. This is a very basically simple device. The maximum voltage the patient can receive from it is 6 7-1/2 Volts. There is absolutely no provision in this device for plugging it into electrical house current.



3 Jeffery M. Kaufholz 11725 Seventh Street East Treasure Island, Florida 3 3706

Page ^2. October 25, 1976

This device is hand held, designed to be used by the patient himself or by another person aiding the patient.

It is assumed that purchase of the device by a lay person will only be through the recommendation or prescription of a licensed physician or therapist.

If this device is approved by you, it will be manufactured and marketed under the name Capri Company, Treasure Island, Florida 33706, this being a fictitous name to be registered under my name in proper legal manner in Pinellas County, Florida. This will be a one man business since there is a very limited market for such a device, but will fill an important need in such cases as mentioned in the first paragraph.

On the basis of the simplicity of this device, its low voltage, and the fact that similar devices have been manufactured and sold by {St. Anthony Hospital, LouisvilleT?Kentucky, I respectfully request that you grant my device" approval under Class I. My device will be labelled: "Muscle Stimulator, manufactured by Capri Company, Treasure Island, Florida 33706. For use only as prescribed by a licensed physician or physical therapist."

Very truly yours,

^m^j\' \ / ^ j . JeffeSy M. Kaufho lzT



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