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Tens Model 8201

by Medical Scientific Instruments

510(k) K820496

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 NumberK820496 Date15 Mar 1982ClearedStatusActive

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  • Withdrawn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, 22 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 Tens Model 8201 is a transcutaneous nerve stimulator designed for pain relief. It functions as an electric stimulator to provide therapeutic nerve stimulation.

This device is classified as an FDA class 2 medical device under regulation number 882.5890. It received 510(k) clearance under K820496 in 1982.

Other devices from Medical Scientific Instruments

  • Trns Mi 8202

    Class II

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the primary function of the TENS Model 8201?

    The TENS Model 8201 is a transcutaneous nerve stimulator designed to provide therapeutic nerve stimulation for the purpose of pain relief.

  • What is the regulatory status of this device?

    The TENS Model 8201 is classified as an FDA class 2 medical device under regulation number 882.5890 and received 510(k) clearance under K820496 in 1982.

  • Who is the manufacturer of the TENS Model 8201?

    The device is manufactured by Medical Scientific Instruments, located in McHenry, Illinois.