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Neuromedics Orions #660-01

by Intermedics, Inc. 510(k)

Active United States

510(k) K822600

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822600 Date24 Sep 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
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 Neuromedics Orions #660-01 is a neurostimulation device designed for the treatment of neurological conditions. Classified under product code GZJ, it is intended for use in neuromodulation therapies, specifically targeting nerve stimulation to alleviate symptoms associated with neurological disorders.

This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of September 24, 1982. It is regulated under the advisory committee for Neurology (NE) and is intended for use in clinical settings where neuromodulation is administered. The device’s specifications and regulatory history are documented under K822600.

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