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FDA 510(k)

BACKCYCLER CPM(TM)

K-Number: K945690 · 1995-06-22

ApplicantErgomedics, Inc.
Decision Date1995-06-22
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BACKCYCLER CPM(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ergomedics, Inc.. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K945690. 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 BACKCYCLER CPM(TM)?

BACKCYCLER CPM(TM) is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Ergomedics, Inc.. The 510(k) number is K945690.

When did BACKCYCLER CPM(TM) receive FDA 510(k) clearance?

BACKCYCLER CPM(TM) received FDA 510(k) clearance on 1995-06-22, under 510(k) number K945690.

Who is the listed applicant for BACKCYCLER CPM(TM)?

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

What is the FDA product code for BACKCYCLER CPM(TM)?

The FDA product code for BACKCYCLER CPM(TM) 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.

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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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