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Thera-Fit

by Aquatherapy Systems, Inc.

510(k) K930821

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 NumberK930821 Date9 Nov 1994ClearedStatusActive

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  • Withdrawn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
ILJ
Device Class
Class II
Regulation
21 CFR Part 890.5100
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Thera-Fit is a bath, hydro-massage device used in physical medicine. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device is manufactured by Aquatherapy Systems, Inc. and has FDA 510(k) clearance under K930821. It is classified as a Class II medical device with product code ILJ and regulation number 890.5100.

Other devices from Aquatherapy Systems, Inc.

  • Aquadyne

    Class II

Questions

AI-generated answers, 24 Sep 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 Thera-Fit device used for?

    The Thera-Fit device is a bath hydro-massage system used in physical medicine to provide therapeutic water-based treatment, as indicated by its classification and intended use in rehabilitation settings.

  • How is the Thera-Fit device supplied or configured for use?

    The Thera-Fit is a bath hydro-massage device designed for installation in clinical or therapeutic environments, intended for use as a stationary unit where patients receive hydro-massage treatment during physical therapy sessions.

  • Is the Thera-Fit device intended for single-use or repeated use?

    The Thera-Fit is a reusable bath hydro-massage device, as it is a fixed installation system designed for multiple patient uses over time, consistent with its classification as a durable medical device in physical medicine.

  • What regulatory pathway was used for the Thera-Fit device?

    The Thera-Fit device received FDA 510(k) clearance through the traditional pathway under submission number K930821, demonstrating substantial equivalence to a legally marketed predicate device.

  • What is the device classification and product code for Thera-Fit?

    Thera-Fit is classified as a Class II medical device with product code ILJ, corresponding to bath hydro-massage devices used in physical medicine, as defined by regulation number 890.5100.