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Table, Treatment & Traction, Hi-Lo

by Will Ross Co.

510(k) K770610

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 NumberK770610 Date8 Apr 1977ClearedStatusActive

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  • Withdrawn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.

The Hi-Lo Table, Treatment and Traction is a powered traction device designed for physical medicine applications. Classified as Equipment, Traction, Powered, it provides adjustable treatment and traction functions to support therapeutic interventions, including spinal decompression and muscle relaxation. Its design facilitates controlled traction forces for patient rehabilitation and pain management in clinical settings.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K770610) with a Traditional review pathway. It operates in physical medicine environments and is intended for use in clinical settings where traction therapy is administered. The device adheres to regulatory standards outlined in 21 CFR 890.5900 and is categorized under product code ITH. No additional sterility or MRI safety specifications are noted in the available data.

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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 Hi-Lo Table, Treatment & Traction used for?

    The Hi-Lo Table, Treatment & Traction is designed for physical medicine applications, specifically to provide controlled traction forces for patient rehabilitation and pain management. It supports therapeutic interventions such as spinal decompression and muscle relaxation, making it ideal for clinical settings where traction therapy is administered.

  • Is the Hi-Lo Table reusable or single-use?

    The Hi-Lo Table is supplied as a reusable medical instrument. This design allows for repeated use in clinical environments, ensuring cost-effectiveness and consistent performance over time.

  • What regulatory pathway does the Hi-Lo Table follow?

    The Hi-Lo Table is regulated under the FDA 510(k) clearance pathway, specifically with Traditional review. It holds clearance number K770610 and adheres to regulatory standards outlined in 21 CFR 890.5900, categorized under product code ITH.

  • Does the Hi-Lo Table require any special sterility or MRI safety considerations?

    No additional sterility or MRI safety specifications are noted for the Hi-Lo Table in the available data. However, as a reusable medical device, proper cleaning and maintenance protocols should be followed to ensure hygiene and functionality.

  • What types of clinical environments is the Hi-Lo Table intended for?

    The Hi-Lo Table is intended for use in clinical settings focused on physical medicine, particularly where traction therapy is administered. Its adjustable traction and treatment functions make it suitable for rehabilitation centers, physical therapy clinics, and other healthcare facilities specializing in musculoskeletal care.