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)

ACE AIM - CPM HAND UNIT

K-Number: K860714 · 1986-03-27

ApplicantBuckman Co., Inc.
Decision Date1986-03-27
Product CodeJFA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACE AIM - CPM HAND UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1986-03-27 under 510(k) number K860714. 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 ACE AIM - CPM HAND UNIT?

ACE AIM - CPM HAND UNIT is a medical device that received FDA 510(k) clearance on 1986-03-27. The listed applicant is Buckman Co., Inc.. The 510(k) number is K860714.

When did ACE AIM - CPM HAND UNIT receive FDA 510(k) clearance?

ACE AIM - CPM HAND UNIT received FDA 510(k) clearance on 1986-03-27, under 510(k) number K860714.

Who is the listed applicant for ACE AIM - CPM HAND UNIT?

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

What is the FDA product code for ACE AIM - CPM HAND UNIT?

The FDA product code for ACE AIM - CPM HAND UNIT is JFA.

Other records listing Buckman Co., 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.

K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEMK974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEMK964252ORTHOCHUCKK950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMK960451WEBB-MORLEY SPINE SYSTEMK950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

View all 111 devices →

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.K931016JACE MODEL H440 HAND CPM DEVICEJace Systems, 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.

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.

↑