Multi-Stim Tens, AP-101081T

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

510(k) Number

K973979 ↗

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

  FDA 510(k) K050104 Active Cleared 16 Feb 2005

• Apex Suction Curette

  Class I

  FDA 510(k) K871384 Active Cleared 22 May 1987

• Acu-Stim Tens, Ap-101082T

  Class II

  FDA 510(k) K973980 Active Cleared 29 Jul 1998

• Apex Medical Digital TENS TS1211, TS1212

  Class II

  FDA 510(k) K021755 Active Cleared 12 Jun 2002

• WiZARD 510 Nasal Mask

  Class II

  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 Multi-Stim Tens AP-101081T used for?

  The Multi-Stim Tens AP-101081T is used for the symptomatic relief and management of chronic intractable pain by applying electrical currents to the body through transcutaneous electrical nerve stimulation (TENS), as indicated in its FDA 510(k) clearance.

• How is the Multi-Stim Tens AP-101081T supplied and what is its regulatory status?

  The device is supplied by Apex Medical Corp. and has received FDA 510(k) clearance under number K973979, classified as a Class II device with product code GZJ, based on a traditional submission determined to be substantially equivalent to a predicate device.

• Is the Multi-Stim Tens AP-101081T intended for single-use or reuse?

  The device data does not specify whether the Multi-Stim Tens AP-101081T is single-use or reusable; however, as a TENS unit, it is typically designed for multiple uses with replaceable electrodes, though users should consult the manufacturer’s labeling for specific reuse instructions.