Com-Tens: A Neurostimulator

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

510(k) Number

K902102 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Apex Medical Minineb & Miniplus

  Class II

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• Apex Suction Curette

  Class I

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• Acu-Stim Tens, Ap-101082T

  Class II

  FDA 510(k) K973980 Active Cleared 29 Jul 1998

• Apex Medical Digital TENS TS1211, TS1212

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  FDA 510(k) K021755 Active Cleared 12 Jun 2002

• WiZARD 510 Nasal Mask

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  FDA 510(k) K193206 Active Cleared 29 Oct 2020

• Micro II Microcurrent Tens

  Class II

  FDA 510(k) K973978 Active Cleared 29 Jul 1998

See all devices from Apex Medical Corp. →

• What is the Com-Tens Neurostimulator used for?

  The Com-Tens Neurostimulator is used in the field of neurology for neurostimulation purposes, providing a specific treatment option for patients.

• How is the Com-Tens Neurostimulator supplied?

  The Com-Tens Neurostimulator is supplied by Apex Medical, Inc., a manufacturer with a specific address and contact information.

• What is the regulatory status of the Com-Tens Neurostimulator?

  The Com-Tens Neurostimulator has been authorized with FDA 510K, with a specific k number, K902102, and is classified under the product code GZJ.

• Is the Com-Tens Neurostimulator a single-use or reusable device?

  The device data does not specify whether the Com-Tens Neurostimulator is single-use or reusable, it is recommended to consult the manufacturer's instructions for use.