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FDA 510(k)

M-BRACE

K-Number: K823882 · 1983-01-17

ApplicantBuckman Consultants
Decision Date1983-01-17
Product CodeIPY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

M-BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Consultants. It received FDA 510(k) clearance on 1983-01-17 under 510(k) number K823882. The device is classified under product code IPY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-BRACE?

M-BRACE is a medical device that received FDA 510(k) clearance on 1983-01-17. The listed applicant is Buckman Consultants. The 510(k) number is K823882.

When did M-BRACE receive FDA 510(k) clearance?

M-BRACE received FDA 510(k) clearance on 1983-01-17, under 510(k) number K823882.

Who is the listed applicant for M-BRACE?

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

What is the FDA product code for M-BRACE?

The FDA product code for M-BRACE is IPY.

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 Buckman Consultants 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.

K830316UNIFLEXK821829UROGARD

Related Devices (Code: IPY)

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.

K823823LUMBOSACRAL SUPPORTDanek Medical, Inc.K812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.K812099CASH ORTHOSISDavid Hendricks, C.P.O.K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.K810554LUMBAR FLEXION BRACEOrthomedicsK810556SPINAL EXTENSION BRACEOrthomedics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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