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NEUROTECH-16 Program System Controller Model 280

by Neurotech, Inc.

510(k) K860315

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 NumberK860315 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  • Withdrawn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, 1 Oct 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-16 Program System Controller Model 280 is a microprocessor-controlled device classified as an Impedance Parameter Finder (IPF) under FDA product code IPF. It is designed to generate and regulate electrical stimulation parameters for neuromuscular applications, utilizing impedance measurement to ensure safe and effective output delivery via surface electrodes.

This device is intended for use in physical medicine settings and operates as a reusable, non-sterile medical instrument. It requires no special storage conditions but must be maintained according to manufacturer guidelines to preserve functionality. The Neurotech-16 Program System Controller Model 280 holds an FDA 510(k) clearance (K860315) under the Traditional 510(k) Review pathway, with clearance granted on June 17, 1986.

Other devices from Neurotech, Inc.

Questions

AI-generated answers, 1 Oct 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-16 Program System Controller Model 280 used for?

    The Neurotech-16 Program System Controller Model 280 is designed to generate and regulate electrical stimulation parameters for neuromuscular applications. It uses impedance measurement technology to ensure safe and effective delivery of stimulation via surface electrodes, making it suitable for physical medicine settings like physical therapy or rehabilitation.

  • Is the Neurotech-16 Program System Controller Model 280 reusable or single-use?

    This device is classified as a reusable, non-sterile medical instrument. It is intended for repeated use in clinical settings, provided it is maintained according to the manufacturer’s guidelines to preserve its functionality and ensure safety.

  • Does the Neurotech-16 Program System Controller Model 280 require special storage conditions?

    No special storage conditions are required for this device. However, it must be stored and maintained in accordance with the manufacturer’s instructions to ensure proper operation and longevity.

  • What type of regulatory clearance does the Neurotech-16 Program System Controller Model 280 hold?

    The device holds an FDA 510(k) clearance under the Traditional 510(k) Review pathway, specifically for use as an Impedance Parameter Finder (IPF). The clearance was granted on June 17, 1986, and it is classified as substantially equivalent to a predicate device.

  • What is the advisory committee associated with this device’s FDA clearance?

    The Neurotech-16 Program System Controller Model 280 was reviewed by the Physical Medicine (PM) Advisory Committee as part of its FDA 510(k) submission process. This committee provides expert input on devices intended for physical medicine applications.