AUTOMOVE, MODEL AM800

K032955 · Danmeter A/S · IPF · Dec 15, 2003 · Physical Medicine

Device Facts

• Record ID: K032955
• Device Name: AUTOMOVE, MODEL AM800
• Applicant: Danmeter A/S
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion

Device Story

AutoMove AM800 is a powered muscle stimulator and biofeedback device. It delivers electrical stimulation to muscles to facilitate re-education, relax spasms, prevent atrophy, increase blood circulation, and maintain range of motion. Used in clinical or home settings under prescription, the device assists patients recovering from stroke or other conditions requiring muscle stimulation. It operates by applying electrical signals to target muscle groups; the biofeedback component allows monitoring of muscle activity. Healthcare providers use the device to support physical therapy goals, potentially improving patient mobility and muscle function.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and intended use.

Technological Characteristics

Powered muscle stimulator and biofeedback device. Class II. Product codes IPF and HCC. Operates via electrical stimulation for muscle re-education and spasm relaxation.

Indications for Use

Indicated for stroke rehabilitation, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2003

Mr. Hanne Nielsen Danmeter A/S Kildemosevej 13 DK-5000 Odense C Denmark

Re: K032955

Device Name: AutoMove, model AM800 Regulation Numbers: 21 CFR 890.5850; 21 CFR 882.5050 Regulation Names: Powered Muscle Stimulator; Biofeedback Device Regulatory Class: Class 2 Product Codes: IPF: HCC Dated: September 16, 2003 Received: September 24, 2003

Dear Mr. Nielsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

{1}------------------------------------------------

Page 2 - Mr. Hanne Nielsen

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

L. Mark N. Millerson

Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number: K032955

AM800 AutoMove Device Name:

Indications for use:

Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion

Danmeter A/S September 12, 2003

Prescription Use × (Part 21 CFR 801 Subpart D)

Over - The - Counter Use _____________________________________________________________________________________________________________________________________________________ ANDROR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Millerson

sion Sign-( wision of General, Restorative ological Devic

KO32955