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FDA 510(k)

REVOLUTION LOWER LIMB CPM UNIT

K-Number: K935808 · 1994-03-18

ApplicantToronto Medical, Inc.
Decision Date1994-03-18
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REVOLUTION LOWER LIMB 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 1994-03-18 under 510(k) number K935808. 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 REVOLUTION LOWER LIMB CPM UNIT?

REVOLUTION LOWER LIMB CPM UNIT is a medical device that received FDA 510(k) clearance on 1994-03-18. The listed applicant is Toronto Medical, Inc.. The 510(k) number is K935808.

When did REVOLUTION LOWER LIMB CPM UNIT receive FDA 510(k) clearance?

REVOLUTION LOWER LIMB CPM UNIT received FDA 510(k) clearance on 1994-03-18, under 510(k) number K935808.

Who is the listed applicant for REVOLUTION LOWER LIMB 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 REVOLUTION LOWER LIMB CPM UNIT?

The FDA product code for REVOLUTION LOWER LIMB 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.

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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.

K945121A3 ANKLE 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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