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FDA 510(k)

ANKLE CALF EXERCISER

K-Number: K942618 · 1994-06-22

ApplicantPrevent Products, Inc.
Decision Date1994-06-22
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANKLE CALF EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Prevent Products, Inc.. It received FDA 510(k) clearance on 1994-06-22 under 510(k) number K942618. 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 ANKLE CALF EXERCISER?

ANKLE CALF EXERCISER is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Prevent Products, Inc.. The 510(k) number is K942618.

When did ANKLE CALF EXERCISER receive FDA 510(k) clearance?

ANKLE CALF EXERCISER received FDA 510(k) clearance on 1994-06-22, under 510(k) number K942618.

Who is the listed applicant for ANKLE CALF EXERCISER?

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

What is the FDA product code for ANKLE CALF EXERCISER?

The FDA product code for ANKLE CALF EXERCISER 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 Prevent Products, 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.

K003284PHLEBOPUMP, MODEL 1000K952975ANKLE CALF EXERCISER PHLEBOPUMP

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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