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FDA 510(k)

BRACE-UP ALL PURPOSE WRIST BAND

K-Number: K823113 · 1982-11-16

ApplicantArco Matic, Inc.
Decision Date1982-11-16
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BRACE-UP ALL PURPOSE WRIST BAND is the device name listed in this FDA 510(k) record. The listed applicant is Arco Matic, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K823113. 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 BRACE-UP ALL PURPOSE WRIST BAND?

BRACE-UP ALL PURPOSE WRIST BAND is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Arco Matic, Inc.. The 510(k) number is K823113.

When did BRACE-UP ALL PURPOSE WRIST BAND receive FDA 510(k) clearance?

BRACE-UP ALL PURPOSE WRIST BAND received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823113.

Who is the listed applicant for BRACE-UP ALL PURPOSE WRIST BAND?

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

What is the FDA product code for BRACE-UP ALL PURPOSE WRIST BAND?

The FDA product code for BRACE-UP ALL PURPOSE WRIST BAND 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 Arco Matic, 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.

K823114BRACE-UP STOCKING KNEE BRACE

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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