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FDA 510(k)

PRO COMFORT TENNIS ELBOW SUPPORT/WRIST

K-Number: K811035 · 1981-04-29

ApplicantScholl, Inc.
Decision Date1981-04-29
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRO COMFORT TENNIS ELBOW SUPPORT/WRIST is the device name listed in this FDA 510(k) record. The listed applicant is Scholl, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K811035. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO COMFORT TENNIS ELBOW SUPPORT/WRIST?

PRO COMFORT TENNIS ELBOW SUPPORT/WRIST is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Scholl, Inc.. The 510(k) number is K811035.

When did PRO COMFORT TENNIS ELBOW SUPPORT/WRIST receive FDA 510(k) clearance?

PRO COMFORT TENNIS ELBOW SUPPORT/WRIST received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811035.

Who is the listed applicant for PRO COMFORT TENNIS ELBOW SUPPORT/WRIST?

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

What is the FDA product code for PRO COMFORT TENNIS ELBOW SUPPORT/WRIST?

The FDA product code for PRO COMFORT TENNIS ELBOW SUPPORT/WRIST is IQI.

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 Scholl, 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.

K813308DOUBLE SEAL TUBEGUAZE STERILE BANDAGE

Related Devices (Code: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred 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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