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FDA 510(k)

A3 ANKLE CPM UNIT

K-Number: K945121 · 1995-02-17

ApplicantToronto Medical, Inc.
Decision Date1995-02-17
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A3 ANKLE CPM UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Toronto Medical, Inc.. It received FDA 510(k) clearance on 1995-02-17 under 510(k) number K945121. 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 A3 ANKLE CPM UNIT?

A3 ANKLE CPM UNIT is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Toronto Medical, Inc.. The 510(k) number is K945121.

When did A3 ANKLE CPM UNIT receive FDA 510(k) clearance?

A3 ANKLE CPM UNIT received FDA 510(k) clearance on 1995-02-17, under 510(k) number K945121.

Who is the listed applicant for A3 ANKLE CPM UNIT?

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

What is the FDA product code for A3 ANKLE CPM UNIT?

The FDA product code for A3 ANKLE CPM UNIT is BXB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Toronto Medical, 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.

K935808REVOLUTION LOWER LIMB CPM UNIT

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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