MODEL HS-2 TENS DEVICE

K962951 · Technalithics Laboratories, Inc. · GZJ · Aug 6, 1997 · Neurology

Device Facts

• Record ID: K962951
• Device Name: MODEL HS-2 TENS DEVICE
• Applicant: Technalithics Laboratories, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.

Device Story

Sportstim Model 2.0 is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It delivers electrical impulses to nerves via skin electrodes to provide symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain. Operated under physician prescription; intended for use by patients to manage pain symptoms. Device functions by modulating nerve signals to inhibit pain perception. Clinical benefit is non-pharmacological pain management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device classification and intended use.

Technological Characteristics

TENS device; electrical stimulation principle; prescription-use form factor; class II device.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, including post-traumatic and post-surgical pain, in patients under physician prescription.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Submission Summary (Full Text)

{0}

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

Mr. Bryan D. Adams
Technalithics, Inc.
7003 Woodway Drive, Suite 315
Waco, Texas 76712

AUG - 6 1997

Re: K962951
Trade Name: Sportstim Model 2.0 TENS Device
Regulatory Class: II
Product Code: 84GZJ
Dated: May 22, 1997
Received: May 23, 1997

Dear Mr. Adams:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{1}

Page 2 - Mr. Bryan D. Adams

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,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

# INDICATIONS FOR USE STATEMENT

510(k) Number: K962951

Device Name: Sportstim Model 2.0 TENS Device

## Indications For Use:

The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahan

Prescription Use ☑ (Per 21 CFR §801.109)

Over The Counter Use