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FDA 510(k)

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION

K-Number: K912537 · 1991-08-16

ApplicantThera Kinetics, Inc.
Decision Date1991-08-16
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Thera Kinetics, Inc.. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912537. 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 JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION?

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Thera Kinetics, Inc.. The 510(k) number is K912537.

When did JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION receive FDA 510(k) clearance?

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912537.

Who is the listed applicant for JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION?

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

What is the FDA product code for JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION?

The FDA product code for JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION 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 Thera Kinetics, 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.

K913227JACE MODEL T300 TOE CPM DEVICEK903467JACE MODEL 100 KNEE CPM DEVICE

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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