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FDA 510(k)

UNIVERSAL WRIST SPLINT & FOREARM SPLINT

K-Number: K823666 · 1982-12-30

ApplicantWarm & Form, Orthopedic Materials
Decision Date1982-12-30
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL WRIST SPLINT & FOREARM SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Warm & Form, Orthopedic Materials. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823666. 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 UNIVERSAL WRIST SPLINT & FOREARM SPLINT?

UNIVERSAL WRIST SPLINT & FOREARM SPLINT is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Warm & Form, Orthopedic Materials. The 510(k) number is K823666.

When did UNIVERSAL WRIST SPLINT & FOREARM SPLINT receive FDA 510(k) clearance?

UNIVERSAL WRIST SPLINT & FOREARM SPLINT received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823666.

Who is the listed applicant for UNIVERSAL WRIST SPLINT & FOREARM SPLINT?

The FDA 510(k) record lists Warm & Form, Orthopedic Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL WRIST SPLINT & FOREARM SPLINT?

The FDA product code for UNIVERSAL WRIST SPLINT & FOREARM SPLINT is ILH.

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Other records listing Warm & Form, Orthopedic Materials 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.

K830245HEAD HALTERK830244TRACTION ACCESSORIESK830243ABDUCTION PILLOWK830246CAST SHOE, CAST BOOTK823663ABDOMINAL BINDERK823661CLAVICLE SUPPORT

View all 24 devices →

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.K823601WRIST SUPPORTFred Sammons, Inc.K823393STAX FINGER SPLINTSOrthopedic Systems, 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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