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FDA 510(k)

WRIST SPLING & FOREARM SPLINT

K-Number: K823165 · 1982-11-16

ApplicantWarm & Form, Orthopedic Materials
Decision Date1982-11-16
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WRIST SPLING & 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 1982-11-16 under 510(k) number K823165. 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 WRIST SPLING & FOREARM SPLINT?

WRIST SPLING & FOREARM SPLINT is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Warm & Form, Orthopedic Materials. The 510(k) number is K823165.

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

WRIST SPLING & FOREARM SPLINT received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823165.

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

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

Related Clinical Trials

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.

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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.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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