NEUROMOVE NM900

K012885 · Dan Med, Inc. · IPF · Nov 8, 2001 · Physical Medicine

Device Facts

• Record ID: K012885
• Device Name: NEUROMOVE NM900
• Applicant: Dan Med, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion

Device Story

NeuroMove NM900 is a powered muscle stimulator and biofeedback device. It functions by providing electrical stimulation to muscles to facilitate re-education and rehabilitation, particularly for stroke patients. The device assists in relaxing muscle spasms, preventing disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion. It is intended for use by healthcare professionals or patients under prescription. The device operates by delivering electrical impulses to target muscle groups, which helps in restoring function and mobility. By providing feedback and stimulation, it aids in the neuromuscular re-education process, potentially improving patient outcomes in physical therapy and rehabilitation settings.

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 device under 21 CFR 890.5850 and 882.5050. Product codes IPF and HCC.

Indications for Use

Indicated for patients requiring stroke rehabilitation, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, increase of local blood circulation, and maintenance or increase of 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

Mr. Thomas Sandgaard President Dan Med, Inc. 4 West Dry Creek Circle Suite 260 Denver, Colorado 80120

Re: K012885

Trade/Device Name: NeuroMove NM900 Regulation Number: 890.5850, 882.5050 Regulation Name: Powered muscle stimulator Biofeedback devices Regulatory Class: II

Product Code: IPF, HCC Dated: August 25, 2001 Received: August 28, 2001

Dear Mr. Sandgaard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the casordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is elassined (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additions, 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 I lease be advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a coregulations administered by other Federal agencies. You must or any I cacal statutes and registements, including, but not limited to: registration and listing (21 compry with an the Net 8 requirements (1); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality byevelily (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Thomas Sandgaard

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification. THC PDA miding of backandary ------------------------------------------------------------------------------------------------------------------------to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific advice to: your vitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 607.10 for his raily, for questions on the promotion and advertising of Compliance at [phone]. Ticalities of Compliance at [phone]. Also, please note the your device, picaso ochare and reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misorananing of Telection of the Act may be obtained from the Other general information on your responsional 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,

Susan Walk, us

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

Enclosure

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NOV 0 82001

Page 1 of 1

KO12885 510(k) Number (if known):

Device Name:

NeuroMove NM900

Indications for Use:

Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X .

OR

Over-The-Counter Use

Susan Walk

Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012885