AXIOM NVP8500

K051135 · Axiom Worldwide, Inc. · IPF · Aug 11, 2005 · Physical Medicine

Device Facts

• Record ID: K051135
• Device Name: AXIOM NVP8500
• Applicant: Axiom Worldwide, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation. PAIN MANAGEMENT - For adjunctive treatment of post-traumatic pain syndromes . - For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation - As an adjunctive treatment in the management of post-surgical pain . problems MUSCLE STIMULATION - Relaxation of Muscle Spasms . - Prevention or Retardation of Tissue Atrophy . - Increasing Local Blood Circulation ● - Muscle Re-education ● - Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous ● thrombosis - . Maintaining or increasing range of motion

Device Story

Axiom NVP8500 is a powered muscle stimulator; delivers electrical impulses to peripheral and motor nerves. Used in clinical settings by healthcare providers. Device functions by applying electrical stimulation to target tissues; output parameters managed by clinician to achieve therapeutic goals: pain relief, muscle spasm reduction, atrophy prevention, circulation improvement, muscle re-education, and venous thrombosis prevention. Benefits include non-pharmacological pain management and physical rehabilitation support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output. Class II device (21 CFR 890.5850). Product codes: IPF, LIH, GXY. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring peripheral nerve stimulation for pain relief (post-traumatic, chronic intractable, post-surgical) and motor nerve stimulation for muscle rehabilitation (spasm relaxation, atrophy prevention, blood circulation, muscle re-education, post-surgical calf stimulation, range of motion maintenance). 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Gibson, Jr. President & CEO Axiom Worldwide 9423 Corporate Lake Drive Tampa, Florida 33624

Re: K051135

Trade/Device Name: Axiom NVP8500 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH, GXY Dated: July 26, 2005 Received: July 28, 2005

Dear Mr. Gibson:

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

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Page 2 - Mr. James J. Gibson Jr.

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 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,

Mark A. Mulkerso

Mark N. Melkerson Acting 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): K051135

Device Name: Axiom NVP8500

## INDICATIONS FOR USE

Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.

## PAIN MANAGEMENT

- For adjunctive treatment of post-traumatic pain syndromes .
- For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
- As an adjunctive treatment in the management of post-surgical pain . problems

## MUSCLE STIMULATION

- Relaxation of Muscle Spasms .
- Prevention or Retardation of Tissue Atrophy .
- Increasing Local Blood Circulation ●
- Muscle Re-education �
- Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous ● thrombosis
- . Maintaining or increasing range of motion

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X ____________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Mark A. Melkerson

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

510(k) Number K051135