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FDA 510(k)

CLUB FOOT CPM MACHINE

K-Number: K903851 · 1990-10-19

ApplicantSmith & Nephew Richards, Inc.
Decision Date1990-10-19
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLUB FOOT CPM MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K903851. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLUB FOOT CPM MACHINE?

CLUB FOOT CPM MACHINE is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K903851.

When did CLUB FOOT CPM MACHINE receive FDA 510(k) clearance?

CLUB FOOT CPM MACHINE received FDA 510(k) clearance on 1990-10-19, under 510(k) number K903851.

Who is the listed applicant for CLUB FOOT CPM MACHINE?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUB FOOT CPM MACHINE?

The FDA product code for CLUB FOOT CPM MACHINE is BXB.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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