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Tremorometer

by Flexable Systems, Inc.

510(k) K010270

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 NumberK010270 Date25 Jul 2001ClearedStatusActive

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  • Withdrawn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, 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 TREMOROMETER is a battery-powered, hand-held, self-contained, programmable device used to measure tremor. It is a transducer device designed for neurology applications and contains a microcomputer component.

The device is supplied as a single unit and is intended for use with a tremor sensor that generates pulse width modulated signals. It is regulated under FDA 510(k) with product code GYD and was determined to be substantially equivalent to the FlexiPlusTM and Actiwatch® devices. The TREMOROMETER is manufactured by Flexable Systems, Inc.

Questions

AI-generated answers, 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.

  • What is the TREMOROMETER used for?

    The TREMOROMETER is a battery-powered, handheld device designed to measure tremor in neurology applications. It contains a microcomputer component and works with a tremor sensor that generates pulse width modulated signals.

  • How is the TREMOROMETER supplied?

    The device is supplied as a single unit and is intended for use with a tremor sensor that generates pulse width modulated signals. It is a self-contained, programmable device requiring no additional components for basic operation.

  • Is the TREMOROMETER reusable or single-use?

    The device is not specified as single-use or reusable in the provided information. It is a battery-powered, programmable device that can be used multiple times, but specific reuse instructions or sterilization requirements are not detailed in the available data.

  • What regulatory approvals does the TREMOROMETER have?

    The TREMOROMETER is regulated under FDA 510(k) clearance with product code GYD. It was determined to be substantially equivalent to the FlexiPlusTM and Actiwatch® devices, with clearance received on July 25, 2001.