AXIOM EPS8000

K050687 · Axiom Worldwide, Inc. · IPF · Jul 28, 2005 · Physical Medicine

Device Facts

• Record ID: K050687
• Device Name: AXIOM EPS8000
• Applicant: Axiom Worldwide, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 28, 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 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 EPS8000 is a powered muscle stimulator; delivers electrical impulses via accessory electrodes to peripheral and motor nerves. Used in clinical settings by healthcare professionals. Provides pain relief through nerve stimulation; facilitates muscle rehabilitation via muscle contraction. Effects include spasm relaxation, atrophy prevention, increased local blood circulation, muscle re-education, and range of motion maintenance. Post-surgical application helps prevent venous thrombosis. Device output is controlled electrical stimulation; clinical decision-making relies on provider assessment of patient pain or rehabilitation needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation via accessory electrodes. Class II device. Product codes: IPF, LIH, GXY. Regulation: 21 CFR 890.5850.

Indications for Use

Indicated for patients requiring peripheral nerve stimulation for pain relief (post-traumatic, chronic intractable, post-surgical) or motor nerve stimulation for muscle rehabilitation (spasm relaxation, atrophy prevention, blood circulation, re-education, venous thrombosis prevention, 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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Public Health Service

JUL 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Gibson Axiom Worldwide, Inc. 9423 Corporate Lake Drive Tampa, FL 33634

Re: K050687

Trade/Device Name: Axiom EPS8000 with accessory electrodes Regulation Number: CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, LIH and GXY Dated: July 22, 2005 Received: July 25, 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

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 (240) 276-_. 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/industry/support/index.html.

Sincerely yours,

Hypt Ruvdu

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): K050687

Device Name: Axiom EPS8000

## 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 the management of post-surgical pain . problems

## MUSCLE STIMULATION

510(k) Number_

- 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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