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MM-1 Movement Monitor

by Axon Instruments, Inc.

510(k) K971318

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 NumberK971318 Date28 Jul 1997ClearedStatusActive

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  • Withdrawn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
GYD
Device Class
Class II
Regulation
21 CFR Part 882.1950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 MM-1 Movement Monitor is a Class II medical device classified as a transducer for tremor. It records patient movement signals to assess tremor activity in neurology applications.

The device was cleared through a traditional 510(k) submission (K971318) and is listed under product code GYD with regulation number 882.1950. It is supplied by Axon Instruments, Inc. in Foster City, California, for use in clinical neurology settings.

Other devices from Axon Instruments, Inc.

Questions

AI-generated answers, 28 Sep 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 MM-1 Movement Monitor used for?

    The MM-1 Movement Monitor is a Class II medical device used as a transducer for tremor. It records patient movement signals to assess tremor activity specifically in neurology applications.

  • How is the MM-1 Movement Monitor supplied?

    The MM-1 Movement Monitor is supplied by Axon Instruments, Inc. in Foster City, California, for use in clinical neurology settings.

  • What is the regulatory status of the MM-1 Movement Monitor?

    The MM-1 Movement Monitor was cleared through a traditional 510(k) submission (K971318) and is listed under product code GYD with regulation number 882.1950.

  • Is the MM-1 Movement Monitor reusable or single-use?

    The device data does not specify whether the MM-1 Movement Monitor is reusable or single-use. This information would need to be obtained directly from the manufacturer or product documentation.