CARE TENS

K984025 · Care Rehab, Inc. · GZJ · Feb 10, 1999 · Neurology

Device Facts

• Record ID: K984025
• Device Name: CARE TENS
• Applicant: Care Rehab, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 10, 1999
• 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

CARE TENS is a portable transcutaneous electrical nerve stimulation (TENS) device for pain management. It delivers electrical stimulation to patients via electrodes to provide symptomatic relief for chronic intractable pain or acute postsurgical/posttraumatic pain. The device is operated by the patient or clinician. It functions by generating electrical output signals; the device utilizes specific jacks and cables compliant with FDA performance standards for electrode lead wires and patient cables. The device is substantially equivalent to the Matrix I predicate device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Portable TENS device; electrical nerve stimulator. Features jacks and cables compliant with FDA performance standards for electrode lead wires and patient cables. Class II device. Electrical output characteristics verified via bench testing.

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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K984025

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## 12 Appendix F: 510(k) Summary

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## 510(k) Summary

| Submitter's Information: | Christian E. Hunt<br>Care Rehab®<br>1124 Dominion Ct<br>McLean, VA 22102 | Phone: [phone]<br>FAX: [phone]. |
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| Date of preparation: | November 9, 1998 | |
| Proprietary Name: | CARE TENSTM | |
| Common Name: | TENS device | |
| Classification Name: | Stimulator, Nerve, Transcutaneous, For Pain Relief<br>84GZJ; 21 CFR 882.5890. | |
| Device Classification: | Class II | |
| Predicate Device: | Matrix I (K895473) | |
| Description of Device: | A portable TENS device for pain control. | |
| Intended Use: | TENS is used for symptomatic relief and management of<br>chronic intractable pain and/or as an adjunctive treatment in the<br>management of postsurgical and posttraumatic acute pain. | |
| Technological Comparison: | The CARE TENS has technological characteristics which<br>are substantially equivalent to those of the predicate device,<br>as determined by bench testing. It differs technologically<br>only by the use of jacks and cables which comply with<br>FDA's Final Rule "Medical Devices; Establishment of a<br>Performance Standard for Electrode Lead Wires and Patient<br>Cables" | |
| Labeling Comparison: | The labeling of the CARE TENS is substantially equivalent to<br>that of the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics<br>or CARE TENS are substantially equivalent to that of the<br>predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE TENS is substantially equivalent in electrical<br>output to the predicate device and any differences between the<br>devices do not pose new questions of safety and effectiveness. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Mr. Christian E. Hunt President Care Rehab and Orthopaedic Products, Inc. P.O. Box 580 22101 McLean, Virginia

Re: K984025 Trade Name: CARE TENS™ Regulatory Class: II Product Code: GZJ November 9, 1998 Dated: November 12, 1998 Received:

Dear Mr. Hunt:

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 The general controls provisions of the Act 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. ਸ 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 In addition, FDA may publish further announcements action. 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. Christian E. Hunt

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 Also, please note the Office of Compliance at [phone]. 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,

[signature]

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 4

984025 510(k) Number:

Device Name: CARE TENS

Indications for Use:

TENS is used for symptomatic relief and management of chronic intractable pain and/or as an I ENO is used for symptomatio reast and of postsurgical and posttraumatic acute pain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division General Re 510(k) Number