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Ness System

by Ness-Neuromuscular Electrical Stimulation Systems

510(k) K022776

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 · Special NumberK022776 Date11 Sep 2002ClearedStatusActive

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  • Withdrawn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, 6 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 Ness System is a portable, one-channel, battery-powered neuromuscular electrical stimulator for personal use. It utilizes surface electrodes held against limbs via specialized splints (hand, forearm, thigh, leg).

The device is intended for maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. It received FDA 510(k) clearance (K022776) on September 11, 2002, and is classified under product code IPF with advisory committee review in Physical Medicine (PM).

Other devices from Ness-Neuromuscular Electrical Stimulation Systems

Questions

AI-generated answers, 6 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 Ness System intended for?

    The Ness System is intended for maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation, as stated in its device description.

  • How is the Ness System powered and what type of stimulation does it deliver?

    The Ness System is a portable, one-channel, battery-powered neuromuscular electrical stimulator that delivers stimulation via surface electrodes held against limbs using specialized splints.

  • What regulatory pathway was used for the Ness System and when was it cleared?

    The Ness System received FDA 510(k) clearance (K022776) on September 11, 2002, and was found substantially equivalent to a predicate device.