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FDA 510(k)

PROTECTIVE RESTRAINT (PROTECTIVE MITT)

K-Number: K963422 · 1996-11-22

ApplicantKenad SG Medical, Inc.
Decision Date1996-11-22
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECTIVE RESTRAINT (PROTECTIVE MITT) is the device name listed in this FDA 510(k) record. The listed applicant is Kenad SG Medical, Inc.. It received FDA 510(k) clearance on 1996-11-22 under 510(k) number K963422. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTIVE RESTRAINT (PROTECTIVE MITT)?

PROTECTIVE RESTRAINT (PROTECTIVE MITT) is a medical device that received FDA 510(k) clearance on 1996-11-22. The listed applicant is Kenad SG Medical, Inc.. The 510(k) number is K963422.

When did PROTECTIVE RESTRAINT (PROTECTIVE MITT) receive FDA 510(k) clearance?

PROTECTIVE RESTRAINT (PROTECTIVE MITT) received FDA 510(k) clearance on 1996-11-22, under 510(k) number K963422.

Who is the listed applicant for PROTECTIVE RESTRAINT (PROTECTIVE MITT)?

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

What is the FDA product code for PROTECTIVE RESTRAINT (PROTECTIVE MITT)?

The FDA product code for PROTECTIVE RESTRAINT (PROTECTIVE MITT) is FMQ.

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 Kenad SG Medical, 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.

K963430PROTECTIVE RESTRAINT (VEST RESTRAINT)K963421PROTECTIVE RESTRAINT (WAIST HOLDER)K962626PATIENT PROTECTIVE LIMB

Related Devices (Code: FMQ)

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.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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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