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Cyclopac CP100 TENS Bandage

by Cyclotechnical Medical Indust., Inc.

510(k) K800576

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800576 Date23 May 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cyclopac CP100 TENS Bandage is a medical device designed to be applied adjacent to an injured portion of a patient's body. It contains electronic circuitry that delivers electric pulses into the body to block or mask pain arising from an injury.

The device features an inner unit with spaced-apart conductive portions that contact the patient's skin and an outer unit that is removably applied upon the inner unit. This device is authorized under FDA 510(k) K800576.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How does the Cyclopac CP100 TENS Bandage function?

    The device utilizes internal electronic circuitry to deliver controlled electric pulses to the patient's skin. These pulses are intended to block or mask pain signals originating from an injury site when the bandage is applied adjacent to the affected area.

  • What is the physical design of the CP100 TENS Bandage?

    The bandage consists of two primary components: an inner unit featuring spaced-apart conductive portions that make direct contact with the patient's skin, and an outer unit that is designed to be removably applied over the inner unit.

  • What is the regulatory status of this device?

    The Cyclopac CP100 TENS Bandage is authorized under FDA 510(k) number K800576. This indicates the device was reviewed and determined to be substantially equivalent to legally marketed predicate devices.