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FDA 510(k)

AIRSTIRRUP PNEUMATIC ANKLE BRACE

K-Number: K780979 · 1978-06-30

ApplicantAircast, Inc.
Decision Date1978-06-30
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIRSTIRRUP PNEUMATIC ANKLE BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Aircast, Inc.. It received FDA 510(k) clearance on 1978-06-30 under 510(k) number K780979. 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 AIRSTIRRUP PNEUMATIC ANKLE BRACE?

AIRSTIRRUP PNEUMATIC ANKLE BRACE is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Aircast, Inc.. The 510(k) number is K780979.

When did AIRSTIRRUP PNEUMATIC ANKLE BRACE receive FDA 510(k) clearance?

AIRSTIRRUP PNEUMATIC ANKLE BRACE received FDA 510(k) clearance on 1978-06-30, under 510(k) number K780979.

Who is the listed applicant for AIRSTIRRUP PNEUMATIC ANKLE BRACE?

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 AIRSTIRRUP PNEUMATIC ANKLE BRACE?

The FDA product code for AIRSTIRRUP PNEUMATIC ANKLE BRACE 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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