Skip to content

NEUROTECH-4 Program Neuromuscular Stimulator 281

by Neurotech, Inc.

510(k) K860314

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 NumberK860314 Date17 Jun 1986ClearedStatusActive

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  • Withdrawn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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
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 Neurotech-4 Program Neuromuscular Stimulator 281 is a neuromuscular electrical stimulator device. It is substantially equivalent to a predicate device and has been cleared under the FDA 510(k) process.

The device is supplied by Neurotech, Inc. and is intended for use in physical medicine settings. It is a Class II medical device with product code IPF and was cleared on June 17, 1986, under K860314.

Other devices from Neurotech, Inc.

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 Neurotech-4 Program Neuromuscular Stimulator 281 used for?

    The Neurotech-4 Program Neuromuscular Stimulator 281 is intended for use in physical medicine settings as a neuromuscular electrical stimulator, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • How is the Neurotech-4 Program Neuromuscular Stimulator 281 supplied and by whom?

    The device is supplied by Neurotech, Inc., located at 815 Connecticut Ave., NW, Washington, DC 20006, as indicated in the manufacturer and address fields of its FDA 510(k) submission.

  • Is the Neurotech-4 Program Neuromuscular Stimulator 281 a single-use or reusable device?

    The device data does not specify whether the Neurotech-4 Program Neuromuscular Stimulator 281 is single-use or reusable; therefore, no determination can be made from the provided information regarding its reusability.

  • What regulatory pathway was used for the Neurotech-4 Program Neuromuscular Stimulator 281?

    The device was cleared through the FDA 510(k) traditional pathway, as indicated by the clearance_type field and the K860314 number, confirming its substantially equivalent status to a predicate device.

  • What are the key identifiers for the Neurotech-4 Program Neuromuscular Stimulator 281 in regulatory databases?

    The device is identified by the K number K860314, product code IPF, device name NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281, and was cleared on June 17, 1986, under the FDA 510(k) system.