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Hydrot

by Sanker Intl., Inc.

510(k) K930918

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 NumberK930918 Date25 May 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  • Withdrawn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
ILO
Device Class
Class II
Regulation
21 CFR Part 890.5720
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Hydrot is a water circulating pack designed for hot or cold therapy. It functions as a medical device intended to provide thermal treatment to patients.

This device is regulated under FDA 510(k) clearance K930918. It is manufactured by Sanker Intl., Inc.

Questions

AI-generated answers, 26 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 primary purpose of the Hydrot device?

    The Hydrot is a medical device intended to provide thermal treatment to patients. It functions as a water circulating pack that can be used for either hot or cold therapy applications.

  • Who is the manufacturer of the Hydrot?

    The Hydrot is manufactured by Sanker Intl., Inc., based in Magalia, California.

  • Is the Hydrot regulated by the FDA?

    Yes, the Hydrot is regulated under FDA 510(k) clearance number K930918. This indicates that the device has been reviewed and cleared for use as a water circulating hot or cold pack.