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Bite Away

by Riemser Pharma

510(k) K160943

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 NumberK160943 Date26 Aug 2016ClearedStatusActive

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  • Withdrawn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, 19 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 Bite Away is an electronic device classified as an Insect Bite Healer (Product Code: IRT), designed for external treatment of insect bites and stings. It provides relief for painful reactions caused by bites from mosquitoes, wasps, bees, hornets, or other biting insects, as well as stings from jellyfish or minor burns.

This device is supplied as a single-use or reusable unit, depending on the model variant, and is intended for home or clinical use. It operates via a non-invasive electrical stimulation mechanism to alleviate discomfort. Authorized under FDA 510(k) clearance (K160943) as substantially equivalent to existing products in the Physical Medicine category, it adheres to regulatory standards for external therapeutic devices without requiring MRI safety classification or special sterility conditions.

Questions

AI-generated answers, 19 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 types of insect bites or stings is the Bite Away device designed to treat, and how does it work to provide relief?

    The Bite Away is specifically designed to relieve discomfort from insect bites and stings, including those from mosquitoes, wasps, bees, hornets, and other biting insects, as well as jellyfish stings and minor burns. It works by delivering non-invasive electrical stimulation to the affected area, which helps alleviate pain and inflammation associated with these reactions.

  • Is the Bite Away device intended for use at home or only in clinical settings, and can it be reused?

    The Bite Away is approved for both home and clinical use. It comes in single-use and reusable models, allowing flexibility depending on the intended application—single-use variants are ideal for home settings where convenience and hygiene are prioritized, while reusable models may suit clinical environments with proper cleaning protocols.

  • Does the Bite Away require any special storage conditions, and is it sterile?

    The Bite Away does not require special sterility conditions for storage, as it is classified as an external therapeutic device. However, since it is designed for direct contact with skin, reusable models should be cleaned and stored according to manufacturer guidelines to maintain hygiene. Single-use variants are pre-packaged for immediate use without additional sterilization steps.

  • What regulatory pathway was followed for the FDA clearance of the Bite Away, and what does ‘substantially equivalent’ mean in this context?

    The Bite Away received FDA clearance through a 510(k) Traditional Review under the Physical Medicine advisory committee category (Product Code: IRT). The term *‘substantially equivalent’* means the device was determined to have the same intended use, technological characteristics, and performance as a legally marketed device already on the market, ensuring it meets regulatory standards without requiring a full de novo review.