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FDA 510(k)

ELBOW CPM ORTHOSIS

K-Number: K925043 · 1993-02-12

ApplicantElectrobionics Corp.
Decision Date1993-02-12
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELBOW CPM ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Electrobionics Corp.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K925043. 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 ELBOW CPM ORTHOSIS?

ELBOW CPM ORTHOSIS is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Electrobionics Corp.. The 510(k) number is K925043.

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

ELBOW CPM ORTHOSIS received FDA 510(k) clearance on 1993-02-12, under 510(k) number K925043.

Who is the listed applicant for ELBOW CPM ORTHOSIS?

The FDA 510(k) record lists Electrobionics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELBOW CPM ORTHOSIS?

The FDA product code for ELBOW CPM ORTHOSIS is BXB.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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