Skip to content

Empi Single Use

by Empi

510(k) K822224

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822224 Date16 Aug 1982ClearedStatusActive

Official records

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  • Withdrawn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
GXY
Device class
Class II
Regulation
21 CFR Part 882.1320
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 Empi Single Use is classified as a neuromuscular electrical stimulation (NMES) electrode (Product Code: GXY), designed for single-patient use in neuromuscular therapy. These electrodes deliver electrical impulses to stimulate muscle contraction, aiding in rehabilitation, pain management, and neuromuscular function restoration. They are intended for use in clinical settings where temporary, targeted muscle activation is required, such as post-injury recovery or neurological rehabilitation.

Supplied as a sterile, single-use device, the Empi Single Use electrodes are intended for professional medical use only. They are regulated under the FDA’s 510(k) clearance process (K822224) and fall under the Neurology Advisory Committee review category. Each electrode is packaged individually to maintain sterility and must be discarded after a single patient application. No MRI safety information is specified, and storage conditions are not detailed in the regulatory submission.

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Empi

See all devices from Empi →