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FDA 510(k)

FULL BODY RESTRAINT SYSTEM

K-Number: K972046 · 1997-08-15

ApplicantGillen Industries
Decision Date1997-08-15
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FULL BODY RESTRAINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gillen Industries. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972046. 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 FULL BODY RESTRAINT SYSTEM?

FULL BODY RESTRAINT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Gillen Industries. The 510(k) number is K972046.

When did FULL BODY RESTRAINT SYSTEM receive FDA 510(k) clearance?

FULL BODY RESTRAINT SYSTEM received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972046.

Who is the listed applicant for FULL BODY RESTRAINT SYSTEM?

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

What is the FDA product code for FULL BODY RESTRAINT SYSTEM?

The FDA product code for FULL BODY RESTRAINT SYSTEM is FMQ.

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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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