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Agar 3K Neuromuscular Stimulator

by Solcoor, Inc.

510(k) K882386

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 NumberK882386 Date18 Oct 1989ClearedStatusActive

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  • Withdrawn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 Agar 3K Neuromuscular Stimulator is a device used for neuromuscular stimulation. It is designed to deliver electrical stimulation to muscles for therapeutic purposes.

The device is supplied by Solcoor, Inc. and has FDA 510(k) clearance with product code IPF. It is intended for use in physical medicine settings, though specific sizes, sterility status, and MRI safety information are not provided in the available data.

Other devices from Solcoor, Inc.