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I.C.E. Box

by Lhs Industries

510(k) K821920

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 NumberK821920 Date31 Aug 1982ClearedStatusActive

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  • Withdrawn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
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
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 I.C.E. Box is a powered inflatable tube massager. It is classified as a physical medicine device intended to provide massage therapy.

This device is regulated under FDA 510(k) clearance K821920. It is manufactured by Lhs Industries and is categorized under regulation number 890.5650.

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 primary purpose of the I.C.E. Box?

    The I.C.E. Box is a physical medicine device intended to provide massage therapy to the user through its powered inflatable tube system.

  • Is this device regulated by the FDA?

    Yes, the I.C.E. Box is regulated under FDA 510(k) clearance number K821920, which indicates it has been found substantially equivalent to other legally marketed devices.

  • Who is the manufacturer of this device?

    The I.C.E. Box is manufactured by Lhs Industries, located in McHenry, Illinois.