MUSCLE PAIN DEVICE (MPD)

K073361 · Stevens Proof of Concept, Inc. · IPF · Mar 18, 2008 · Physical Medicine

Device Facts

• Record ID: K073361
• Device Name: MUSCLE PAIN DEVICE (MPD)
• Applicant: Stevens Proof of Concept, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

1. Relaxation of muscle spasms. 2. Muscle re-education. 3. Maintaining or increasing range of motion.

Device Story

Muscle Device (MD) is a powered muscle stimulator; functions by delivering electrical stimulation to muscles. Used for relaxation of muscle spasms, muscle re-education, and maintaining or increasing range of motion. Operated by healthcare professionals in clinical settings. Device provides therapeutic electrical output to target muscle groups to achieve physiological effects. Benefits include improved muscle function and mobility for patients with indicated conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; Class II device; 21 CFR 890.5850.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, muscle re-education, or maintenance/increase of range of motion. Prescription use only.

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

Stevens Proof of Concept. Inc. % Underwriters Laboratories, Inc Mr. Jeff D. Rongero Research Triangle Park Division 12 Laboratory Drive P.O. Box 13995 Research Triangle, North Carolina 27709

MAR 1 8 2008

Re: K073361 Trade/Device Name: Muscle Device (MD) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 29, 2008 Received: March 3, 2008

Dear Mr. Rongero:

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

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Page 2 - Mr. Jeff D. Rongero

forth in the quality systems (QS) regulation (21 CFR Part 820); and if 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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millhusan

Mark N. Melkerson 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 (if known): Ko2 336|

Device Name: Muscle Device (MD)

Indications for Use:

- 1. Relaxation of muscle spasms.
- 2. Muscle re-education.
- 3. Maintaining or increasing range of motion.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soulu
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number_K07336/

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