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FDA 510(k)

JACE MODEL H440 HAND CPM DEVICE

K-Number: K931016 · 1994-06-22

ApplicantJace Systems, Inc.
Decision Date1994-06-22
Product CodeJFA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JACE MODEL H440 HAND 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 1994-06-22 under 510(k) number K931016. The device is classified under product code JFA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JACE MODEL H440 HAND CPM DEVICE?

JACE MODEL H440 HAND CPM DEVICE is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Jace Systems, Inc.. The 510(k) number is K931016.

When did JACE MODEL H440 HAND CPM DEVICE receive FDA 510(k) clearance?

JACE MODEL H440 HAND CPM DEVICE received FDA 510(k) clearance on 1994-06-22, under 510(k) number K931016.

Who is the listed applicant for JACE MODEL H440 HAND 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 H440 HAND CPM DEVICE?

The FDA product code for JACE MODEL H440 HAND CPM DEVICE is JFA.

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.K931781JACE TRI-STIM DEVICEK922185JACE KNEE EXTENSION SYSTEM -- MODIFICATIONK921351JACE MODEL PM-410 HAND CPM DEVICEK920380JACE MODEL W550 WRIST CPM DEVICE

Related Devices (Code: JFA)

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.

K945803THERMAFLEX, MODEL SD 55 C.P.M.H.Burke Neutech, Inc.K933418HAND THERAPY ASSOSTBardon Ent., Inc.K921351JACE MODEL PM-410 HAND CPM DEVICEJace Systems, Inc.K900794MOBILIMB H3 HAND CPM UNITToronto Medical Corp.K900581DANNIFLEX CPM 880(TM)Buckman Co., Inc.K880686TORONTO/MOBILIMB HAND C.P.M.Toronto Medical Corp.

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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