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FDA 510(k)

VELCRO FINGER/TOE SPLINT

K-Number: K812654 · 1981-09-25

ApplicantMaddak, Inc.
Decision Date1981-09-25
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VELCRO FINGER/TOE SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812654. The device is classified under product code ILH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELCRO FINGER/TOE SPLINT?

VELCRO FINGER/TOE SPLINT is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Maddak, Inc.. The 510(k) number is K812654.

When did VELCRO FINGER/TOE SPLINT receive FDA 510(k) clearance?

VELCRO FINGER/TOE SPLINT received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812654.

Who is the listed applicant for VELCRO FINGER/TOE SPLINT?

The FDA 510(k) record lists Maddak, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELCRO FINGER/TOE SPLINT?

The FDA product code for VELCRO FINGER/TOE SPLINT is ILH.

Related Clinical Trials

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Other records listing Maddak, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K841700WALK & ROLLK841698HEAT PACKK841695CRAWLERK841697HYDRO-THERO PADK841693STANDING FRAMEK841692PRONE STANDER

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Related Devices (Code: ILH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K832144SPLINT WOODVermont Wood Industries, Inc.K831548SPLINTSFred Sammons, Inc.K823647FINGER EXTENSION SPLINTFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic MaterialsK823601WRIST SUPPORTFred Sammons, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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