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FDA 510(k)

AIRCAST TENNIS ARM BAND

K-Number: K810288 · 1981-02-12

ApplicantAircast, Inc.
Decision Date1981-02-12
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIRCAST TENNIS ARM BAND is the device name listed in this FDA 510(k) record. The listed applicant is Aircast, Inc.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810288. 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 AIRCAST TENNIS ARM BAND?

AIRCAST TENNIS ARM BAND is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Aircast, Inc.. The 510(k) number is K810288.

When did AIRCAST TENNIS ARM BAND receive FDA 510(k) clearance?

AIRCAST TENNIS ARM BAND received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810288.

Who is the listed applicant for AIRCAST TENNIS ARM BAND?

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

What is the FDA product code for AIRCAST TENNIS ARM BAND?

The FDA product code for AIRCAST TENNIS ARM BAND is IQI.

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Other records listing Aircast, 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.

K024019ARTERIALFLOW SYSTEM, MODEL 32AK023800VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017K992454VENAFLOW SYSTEM, MODEL 30AK964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSK961676AIRCAST VENAFLOW SYSTEM (MODIFICATION)K933977AIRCAST EDEMAFLOW SYSTEM

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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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