IMPULSE HVG

K970847 · Armstrong Industries, Inc. · IPF · Sep 10, 1997 · Physical Medicine

Device Facts

• Record ID: K970847
• Device Name: IMPULSE HVG
• Applicant: Armstrong Industries, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications: - relaxation of muscle spasm - prevention or retardation of disuse atrophy - increasing local blood circulation, and - maintaining or increasing range of motion

Device Story

Impulse HVG is a high-voltage galvanic (HVG) stimulator used in clinical settings by healthcare professionals. Device delivers electrical stimulation to patient tissues to achieve therapeutic goals: muscle spasm relaxation, atrophy prevention, circulation improvement, and range of motion maintenance. Operation involves applying electrodes to patient; device generates electrical pulses to stimulate muscle/nerve tissue. Output is controlled by clinician to manage therapeutic intensity. Benefits include non-pharmacological management of musculoskeletal conditions and physical therapy support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to predicate device.

Technological Characteristics

High-voltage galvanic (HVG) stimulator. Electrical stimulation output. Class II device. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, and 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.

Predicate Devices

• PGS 3000

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# SEP 10 1997

Mr. John P. Landino
President
Sterling Medical Technologies, Inc.
801 Jupiter Road, Suite 102
Plano, Texas 75074

Re: K970847
Impulse HVG
Regulatory Class: II
Product Code: IPF
Dated: August 18, 1997
Received: August 21, 1997

Dear Mr. Landino:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. John P. Landino

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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

Enclosure

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# INDICATIONS FOR USE

Prescribing Information

The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications:

- relaxation of muscle spasm
- prevention or retardation of disuse atrophy
- increasing local blood circulation, and
- maintaining or increasing range of motion

The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).

Prescription Use ☑
(Per 21 CFR 801.109)

Prescription Use ☐
(Per 21 CFR 801.109)


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