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ActiWatch

by Mini-Mitter Co., Inc.

510(k) K983533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK983533 Date23 Mar 1999ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0324-2008 FDA Unclassified (pre-2012) initiated 27 Jun 2007 on shared 510(k) K983533
    • Terminated Z-0327-2008 FDA Unclassified (pre-2012) initiated 27 Jun 2007 on shared 510(k) K983533
    • Terminated Z-0326-2008 FDA Unclassified (pre-2012) initiated 27 Jun 2007 on shared 510(k) K983533

    Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
GWQ
Device Class
Class II
Regulation
21 CFR Part 882.1400
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 ActiWatch is a wearable activity monitoring device designed to record and analyze movement patterns over extended periods. It is classified as a full-montage standard electroencephalograph-related device under regulatory category GWQ, primarily used in neurology for assessing motor activity, sleep patterns, and circadian rhythms. Its compact, non-invasive design allows for continuous, unobtrusive data collection, making it suitable for both clinical and research applications.

The ActiWatch is supplied as a reusable, non-sterile device intended for ambulatory use in clinical or research settings. It operates without MRI compatibility restrictions and is available in a single form factor. Storage requires protection from extreme temperatures and physical damage. Authorized under FDA 510(k) clearance (K983533) as substantially equivalent, it adheres to regulatory standards outlined in 882.1400 for neurology-related devices. No third-party certification is required.

Other devices from Mini-Mitter Co., Inc.

Questions

AI-generated answers, 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.

  • What is the ActiWatch used for in clinical settings?

    The ActiWatch is designed to record and analyze movement patterns continuously over extended periods. It is primarily used in neurology to assess motor activity, sleep patterns, and circadian rhythms. Its compact, non-invasive design allows for unobtrusive data collection, making it ideal for both clinical evaluations and research studies.

  • Is the ActiWatch reusable or single-use?

    The ActiWatch is supplied as a reusable device. It is intended for ambulatory use in clinical or research settings and is not classified as a single-use item. Proper care and maintenance are required to ensure its continued functionality and accuracy.

  • Does the ActiWatch require sterilization?

    No, the ActiWatch is non-sterile and is not intended for sterile procedures. It is designed for non-invasive, ambulatory use where sterility is not a requirement. Cleaning and handling procedures should follow manufacturer guidelines to maintain hygiene.

  • What storage conditions are necessary for the ActiWatch?

    The ActiWatch should be stored in a protected environment to avoid exposure to extreme temperatures and physical damage. Proper storage ensures the device remains functional and accurate for its intended use in monitoring activity and sleep patterns.

  • Is the ActiWatch MRI-compatible?

    No, the ActiWatch does not have MRI compatibility restrictions mentioned in its specifications. Users should confirm compatibility with their specific MRI protocols and consult manufacturer guidelines before use in an MRI environment.