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Traction 230

by Tri W-G, Inc.

510(k) K830088

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 NumberK830088 Date24 Jan 1983ClearedStatusActive

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  • Withdrawn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
ITH
Device Class
Class II
Regulation
21 CFR Part 890.5900
Advisory Committee
Physical Medicine
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.

Equipment, Traction, Powered is a device used to apply a pulling force to the body for therapeutic purposes. It is designed to provide mechanical traction for the treatment of musculoskeletal conditions.

This device is supplied as reusable equipment and is intended for use in clinical settings such as physical medicine departments. It has received FDA 510(k) clearance under product code ITH and regulation number 890.5900, with a decision of substantially equivalent granted on January 24, 1983.

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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 TRACTION 230 used for?

    The TRACTION 230 is a powered traction device designed to apply a pulling force to the body for therapeutic purposes, specifically to provide mechanical traction for the treatment of musculoskeletal conditions in clinical settings such as physical medicine departments.

  • Is the TRACTION 230 reusable or single-use?

    The TRACTION 230 is supplied as reusable equipment, meaning it is intended for multiple uses after appropriate cleaning and maintenance, as indicated in its device description and regulatory documentation.

  • What regulatory pathway was used for the TRACTION 230?

    The TRACTION 230 received FDA 510(k) clearance under submission K830088, with a determination of substantial equivalence granted on January 24, 1983, based on its similarity to a legally marketed predicate device.