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FDA 510(k)

ACCUFLEX DYNAMIC ELBOW ORTHOSIS

K-Number: K926391 · 1993-07-22

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1993-07-22
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCUFLEX DYNAMIC ELBOW ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K926391. 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 ACCUFLEX DYNAMIC ELBOW ORTHOSIS?

ACCUFLEX DYNAMIC ELBOW ORTHOSIS is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K926391.

When did ACCUFLEX DYNAMIC ELBOW ORTHOSIS receive FDA 510(k) clearance?

ACCUFLEX DYNAMIC ELBOW ORTHOSIS received FDA 510(k) clearance on 1993-07-22, under 510(k) number K926391.

Who is the listed applicant for ACCUFLEX DYNAMIC ELBOW ORTHOSIS?

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

What is the FDA product code for ACCUFLEX DYNAMIC ELBOW ORTHOSIS?

The FDA product code for ACCUFLEX DYNAMIC ELBOW ORTHOSIS is IQI.

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Other records listing Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

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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.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, Inc.K831615DROP FOOT BRACEEdward Dilauro, Jr.

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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