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FDA 510(k)

AIRCAST PNEUMATIC KNEE BRACE

K-Number: K812094 · 1981-08-13

ApplicantAircast, Inc.
Decision Date1981-08-13
Product CodeITQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIRCAST PNEUMATIC KNEE 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 1981-08-13 under 510(k) number K812094. The device is classified under product code ITQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRCAST PNEUMATIC KNEE BRACE?

AIRCAST PNEUMATIC KNEE BRACE is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Aircast, Inc.. The 510(k) number is K812094.

When did AIRCAST PNEUMATIC KNEE BRACE receive FDA 510(k) clearance?

AIRCAST PNEUMATIC KNEE BRACE received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812094.

Who is the listed applicant for AIRCAST PNEUMATIC KNEE 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 AIRCAST PNEUMATIC KNEE BRACE?

The FDA product code for AIRCAST PNEUMATIC KNEE BRACE is ITQ.

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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: ITQ)

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.

K831044LIMITED MOTION FUNCTIONAL KNEE BRACEOrthopedic Systems, Inc.K831310BRACE C.T.Innovation Sports, Inc.K823658DELUXE KNEE IMMOBILIZER(UNIVERSAL)Warm & Form, Orthopedic MaterialsK823397ANATOMIC FRACTURE BRACEOrthopedic Systems, Inc.K823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic MaterialsK812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, 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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