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Remote Speed Control

by Th Charters, Inc.

510(k) K851946

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 NumberK851946 Date19 Jul 1985ClearedStatusActive

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  • Withdrawn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
ISD
Device Class
Class II
Regulation
21 CFR Part 890.5360
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

This device is a remote speed control unit classified as an exerciser measuring device within the physical medicine specialty. It is designed to regulate and maintain consistent speed output during therapeutic or rehabilitative exercise sessions.

The device is supplied by Th Charters, Inc. and operates under FDA 510(k) authorization with regulation number 890.5360. It is a Class II medical device cleared under the Traditional 510(k) pathway with a substantially equivalent decision. The device is intended for use in clinical or home-based settings where speed modulation during exercise is required, and it is subject to standard regulatory controls for device class 2.

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