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AT64 SCR

by Autoject Systems, Inc.

510(k) K930577

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 NumberK930577 Date18 May 1995ClearedStatusActive

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  • Withdrawn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
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AT64 SCR is a biofeedback device designed to assist in the assessment and treatment of neurological conditions. It provides real-time feedback to patients undergoing neuromuscular or neurophysiological rehabilitation, helping to improve motor control and functional outcomes through targeted biofeedback signals.

This device is intended for use in clinical settings, such as neurology departments, and is classified as a Class II medical device under FDA regulations. Supplied as a reusable system, it requires proper sterilization and maintenance as specified by the manufacturer. The AT64 SCR has received FDA 510(k) clearance (K930577) under the product code HCC, with a decision date of May 18, 1995.

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