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AQUADYNE

by Aquatherapy Systems, Inc.

510(k) K930820

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 NumberK930820 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  • Withdrawn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, 21 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 AQUADYNE is a Bath, Hydro-Massage device used in physical medicine applications. It is designed to provide hydrotherapy treatments through water massage functionality.

The AQUADYNE is supplied as a Class II medical device with FDA 510K clearance (K930820) and is intended for use in physical medicine settings. The device is manufactured by Aquatherapy Systems, Inc. and is regulated under product code ILJ.

Other devices from Aquatherapy Systems, Inc.

  • Thera-Fit

    Class II

Questions

AI-generated answers, 21 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 AQUADYNE device used for?

    The AQUADYNE is a Bath, Hydro-Massage device designed for physical medicine applications to provide hydrotherapy treatments through water massage functionality.

  • How is the AQUADYNE device supplied?

    The AQUADYNE is supplied as a Class II medical device manufactured by Aquatherapy Systems, Inc. and is intended for use in physical medicine settings.

  • What is the regulatory status of the AQUADYNE device?

    The AQUADYNE has FDA 510K clearance (K930820) and is regulated under product code ILJ, with a decision code of SESE indicating it is substantially equivalent.

  • What are the specifications of the AQUADYNE device?

    The AQUADYNE is a hydro-massage bath device with FDA clearance number K930820, manufactured by Aquatherapy Systems, Inc. in Lafayette Hill, PA, and is classified under product code ILJ.