Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JACE MODEL W550 WRIST CPM DEVICE

K-Number: K920380 · 1992-02-11

ApplicantJace Systems, Inc.
Decision Date1992-02-11
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JACE MODEL W550 WRIST CPM DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Jace Systems, Inc.. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K920380. 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 W550 WRIST CPM DEVICE?

JACE MODEL W550 WRIST CPM DEVICE is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Jace Systems, Inc.. The 510(k) number is K920380.

When did JACE MODEL W550 WRIST CPM DEVICE receive FDA 510(k) clearance?

JACE MODEL W550 WRIST CPM DEVICE received FDA 510(k) clearance on 1992-02-11, under 510(k) number K920380.

Who is the listed applicant for JACE MODEL W550 WRIST CPM DEVICE?

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

What is the FDA product code for JACE MODEL W550 WRIST CPM DEVICE?

The FDA product code for JACE MODEL W550 WRIST CPM DEVICE 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 Jace Systems, 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.

K933059ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.K931016JACE MODEL H440 HAND CPM DEVICEK931781JACE TRI-STIM DEVICEK922185JACE KNEE EXTENSION SYSTEM -- MODIFICATIONK921351JACE MODEL PM-410 HAND 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.

↑