Model 100 Activity Monitor

by Telecom Medical, Inc.

510(k) K011429

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

510(k) K011429↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK011429	Date13 Jul 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K011429
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, 25 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 Model 100 Activity Monitor is a transducer device classified under product code GYD and regulation number 882.1950, with a medical specialty designation in Neurology. It received FDA 510(k) clearance (K011429) on July 13, 2001, as substantially equivalent to a predicate device, following a traditional review process by the Neurology advisory committee.

The device is manufactured by Telecom Medical, Inc., located at 10900 Lucky Oak Ct., Cupertino, CA 95014. It is supplied as a single unit under the K011429 authorization, with no indication of sterility, single-use or reusable status, MRI safety, or storage conditions provided in the data. No clinical indications, intended use, or operational details are specified in the supplied information.