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HYDROTONE Bath Hydro-Massage

by North American Technical Services Corp.

510(k) K974321

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 NumberK974321 Date22 Jun 1998ClearedStatusActive

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  • Withdrawn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)

Full name
Hydrotone
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, 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.

The HYDROTONE Bath Hydro-Massage is a Class 2 Physical Medicine device classified as a Bath, Hydro-Massage. It is intended for use in physical medicine applications.

The device is supplied as a single-use item and is sterilized. It is cleared under FDA 510(k) K974321 with a Traditional clearance type. The device is stored at room temperature.

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