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Bionicare Stimulator System Model BIO-1000

by Murray Electronics

510(k) K971437

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 NumberK971437 Date22 Jul 1997ClearedStatusActive

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  • Withdrawn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
NYN
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Bionicare Stimulator System Model Bio-1000 is a rechargeable battery-operated transcutaneous electrical nerve stimulation (TENS) device. It generates a monophasic spike-shaped pulse with adjustable amplitude (0-12V peak) at a fixed frequency of 100 ± 5 Hz and delivers electrical stimulation via a single channel using electrodes applied to the hand and arm with conductive gel.

The device is supplied as a rechargeable battery-operated system for use in clinical or home settings. It is indicated as an adjunctive therapy for reducing pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by physician's global evaluation. The device has received FDA 510(k) clearance under K971437 and is classified as a Class II device under regulation number 882.5890 with product code NYN.

Other devices from Murray Electronics

Questions

AI-generated answers, 21 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 Bionicare Stimulator System Model Bio-1000 used for?

    It is indicated as an adjunctive therapy for reducing pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by physician's global evaluation, using transcutaneous electrical nerve stimulation via electrodes on the hand and arm.

  • How is the Bionicare Stimulator System Model Bio-1000 powered and supplied?

    It is a rechargeable battery-operated system supplied for use in clinical or home settings, generating electrical stimulation through a single channel with adjustable amplitude (0-12V peak) and fixed frequency of 100 ± 5 Hz using conductive gel-applied electrodes.

  • What type of electrical stimulation does the Bionicare Stimulator System Model Bio-1000 deliver?

    It delivers a monophasic spike-shaped pulse with adjustable amplitude (0-12V peak) at a fixed frequency of 100 ± 5 Hz via a single channel, using transcutaneous electrical nerve stimulation (TENS) technology through electrodes placed on the hand and arm.