CLASSIC TENS

K020437 · Care Rehab, Inc. · GZJ · Mar 15, 2002 · Neurology

Device Facts

• Record ID: K020437
• Device Name: CLASSIC TENS
• Applicant: Care Rehab, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

Device Story

CLASSIC TENS is a portable transcutaneous electrical nerve stimulator for pain management. Device delivers electrical stimulation to patient via electrode lead wires. Intended for symptomatic relief of chronic intractable pain and adjunctive management of postsurgical and posttraumatic acute pain. Operation involves user-controlled electrical output settings. Bench testing confirms electrical output characteristics are substantially equivalent to predicate device. Device utilizes jacks and cables compliant with FDA performance standards for electrode lead wires.

Clinical Evidence

Bench testing only.

Technological Characteristics

Portable transcutaneous electrical nerve stimulator; electrical output; utilizes jacks and cables compliant with FDA Final Rule for electrode lead wires (21 CFR 882.5890).

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain and as adjunctive treatment for postsurgical and posttraumatic acute pain.

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.

Predicate Devices

• Matrix I (K895473)

Submission Summary (Full Text)

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#### 11 Appendix E: 510 (k) Summary

# 510(k) Summary

Stimulator, Nerve, Transcutaneous, For Pain Relief

A portable TENS device for pain control.

postsurgical and posttraumatic acute pain.

KD20437

Submitter's Information:

Christian E. Hunt Care Rehab 1124 Dominion Ct McLean, VA 22102

February 5, 2002

CLASSIC TENS™

84GZJ; 21 CFR 882.5890.

Matrix I (K895473)

Patient Cables"

of the predicate device.

TENS device

Class II

Phone: [phone] FAX: [phone].

Date of preparation:

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Predicate Device:

Description of Device:

Intended Use:

Technological Comparison:

Labeling Comparison:

Nonclinical Testing:

Clinical Testing:

Conclusions from Testing:

Not applicable.

TENS™ are substantially equivalent to that of the predicate device.

The CLASSIC TENSTM is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.

TENS is used for symptomatic relief and management of chronic

intractable pain and/or as an adjunctive treatment in the management of

The CLASSIC TENSTM has technological characteristics which are

substantially equivalent to those of the predicate device, as determined by bench testing. It differs technologically only by the use of jacks and cables which comply with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and

The labeling of the CLASSIC TENS™ is substantially equivalent to that

Bench testing demonstrated that the output characteristics or CLASSIC

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Mr. Christian E. Hunt Care Rehab, Inc. P. O. Box 580 1124 Dominion Court McLean, Virginia 22102

Re: K020437

Trade Name: CLASSIC TENSTM Regulation Number: 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Code: GZJ Dated: February 5, 2002 . Received: February 8, 2002

Dear Mr. Hunt:

We have reviewed your Section 510(k) premarket 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) 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. Christian Hunt

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loket withination. The FDA finding of substantial equivalence of your device to a legally premated 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Malm M Mllersa

Witten. Ph.D .. 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 4

510(k) Number:

Device Name: CLASSIC TENS™

Indications for Use:

TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mcllerson
(Division Sign-Off)

510(k) N

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