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Han-D-Aid

by Salmon Ent.

510(k) K924793

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 NumberK924793 Date19 Oct 1993ClearedStatusActive

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Hand-Aid is a hand injury dressing designed to provide immediate, sterile coverage for minor hand wounds, abrasions, or lacerations. It is classified under the FDA product code FMI (Finger, Hand, and Toe Dressings) and is intended for temporary wound protection and minor trauma management in general hospital settings.

Supplied as a single-use, sterile dressing, the Hand-Aid is intended for use in clinical environments where quick, accessible wound care is required. It is not intended for MRI use and is packaged for individual application. Authorized under FDA 510(k) clearance (K924793), the device was granted Substantially Equivalent status in 1993 and remains compliant with traditional review pathways.

Questions

AI-generated answers, 1 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 the Hand-Aid dressing designed for?

    The Hand-Aid is specifically designed to provide immediate, sterile coverage for minor hand wounds, abrasions, or lacerations. It is intended for temporary wound protection and minor trauma management in clinical environments where quick and accessible care is essential, such as general hospital settings.

  • Is the Hand-Aid dressing sterile and single-use?

    Yes, the Hand-Aid is supplied as a sterile, single-use dressing. Each package is intended for one-time application to ensure hygiene and prevent cross-contamination, making it ideal for clinical use where sterility is critical.

  • Can the Hand-Aid be used in MRI environments?

    No, the Hand-Aid is explicitly not intended for MRI use. This limitation is noted in the device’s specifications, so it should not be used in magnetic resonance imaging settings.

  • How is the Hand-Aid packaged for clinical use?

    The Hand-Aid is packaged individually for single application, ensuring sterility and ease of access in clinical settings. Each package is designed to be opened and applied directly to the wound without compromising its sterile field.

  • What regulatory pathway was followed for FDA clearance of the Hand-Aid?

    The Hand-Aid received FDA clearance under the 510(k) pathway with the reference number K924793. It was granted Substantially Equivalent status in 1993 through the traditional review process, ensuring compliance with regulatory standards for finger, hand, and toe dressings (product code FMI).