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FDA 510(k)

PROTECTIVE RESTRAINT (WAIST HOLDER)

K-Number: K963421 · 1996-11-22

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

Device Summary

PROTECTIVE RESTRAINT (WAIST HOLDER) 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 K963421. 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 (WAIST HOLDER)?

PROTECTIVE RESTRAINT (WAIST HOLDER) 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 K963421.

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

PROTECTIVE RESTRAINT (WAIST HOLDER) received FDA 510(k) clearance on 1996-11-22, under 510(k) number K963421.

Who is the listed applicant for PROTECTIVE RESTRAINT (WAIST HOLDER)?

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 (WAIST HOLDER)?

The FDA product code for PROTECTIVE RESTRAINT (WAIST HOLDER) 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.

K963422PROTECTIVE RESTRAINT (PROTECTIVE MITT)K963430PROTECTIVE RESTRAINT (VEST RESTRAINT)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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