(84 days)
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
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "AutoMove, model AM800." This letter determines that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document is an FDA clearance letter, not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications.
The letter focuses on regulatory approval based on substantial equivalence, which means it compares the new device to existing approved devices without necessarily presenting a full clinical study with acceptance criteria and direct performance evaluation against those criteria.
Therefore, I cannot provide the requested information from the given text.
To obtain the information you're asking for, you would typically need to refer to:
- The original 510(k) submission document itself.
- Clinical study reports that would have been part of that submission or publicly published.
- The applicant's (Danmeter A/S) technical documentation or website.
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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
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
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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
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).