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Li's Itch Stopper

by Hontech Foundation For Medical Technology

510(k) K963824

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 NumberK963824 Date12 Dec 1996ClearedStatusActive

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  • Withdrawn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
IRT
Device Class
Class II
Regulation
21 CFR Part 890.5740
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Li's Itch Stopper is a medical device classified under product code IRT for physical medicine applications. The device is designed to address itching conditions, though the specific mechanism of action is not detailed in the provided information.

Li's Itch Stopper is manufactured by Hontech Foundation For Medical Technology and received FDA 510(k) clearance on December 12, 1996, with decision code SESE (substantially equivalent). The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

Questions

AI-generated answers, 6 Oct 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 Li's Itch Stopper used for?

    Li's Itch Stopper is a medical device designed to address itching conditions. It is classified under product code IRT for physical medicine applications, though the specific mechanism of action is not detailed in the provided information.

  • Is Li's Itch Stopper a single-use device or reusable?

    The device information does not specify whether Li's Itch Stopper is designed for single-use or multiple uses. No details regarding sterility or reuse instructions are provided in the available data.

  • What regulatory approval has Li's Itch Stopper received?

    Li's Itch Stopper received FDA 510(k) clearance on December 12, 1996, with decision code SESE (substantially equivalent). It was reviewed under the Physical Medicine advisory committee and classified under product code IRT.

  • Who manufactures Li's Itch Stopper?

    Li's Itch Stopper is manufactured by Hontech Foundation For Medical Technology, located in Cambridge, MA. The contact person listed is HUAN-CHEN LI, and the device received its FDA clearance with K number K963824.