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FDA 510(k)

ROTATION BOOT

K-Number: K823160 · 1982-11-10

ApplicantWarm & Form, Orthopedic Materials
Decision Date1982-11-10
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROTATION BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Warm & Form, Orthopedic Materials. It received FDA 510(k) clearance on 1982-11-10 under 510(k) number K823160. 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 ROTATION BOOT?

ROTATION BOOT is a medical device that received FDA 510(k) clearance on 1982-11-10. The listed applicant is Warm & Form, Orthopedic Materials. The 510(k) number is K823160.

When did ROTATION BOOT receive FDA 510(k) clearance?

ROTATION BOOT received FDA 510(k) clearance on 1982-11-10, under 510(k) number K823160.

Who is the listed applicant for ROTATION BOOT?

The FDA 510(k) record lists Warm & Form, Orthopedic Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTATION BOOT?

The FDA product code for ROTATION BOOT is IQI.

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Other records listing Warm & Form, Orthopedic Materials 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.

K830245HEAD HALTERK830244TRACTION ACCESSORIESK830243ABDUCTION PILLOWK830246CAST SHOE, CAST BOOTK823663ABDOMINAL BINDERK823661CLAVICLE SUPPORT

View all 24 devices →

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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