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FDA 510(k)

ROLL BELT

K-Number: K963460 · 1996-10-09

ApplicantSkil-Care Corp.
Decision Date1996-10-09
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROLL BELT is the device name listed in this FDA 510(k) record. The listed applicant is Skil-Care Corp.. It received FDA 510(k) clearance on 1996-10-09 under 510(k) number K963460. 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 ROLL BELT?

ROLL BELT is a medical device that received FDA 510(k) clearance on 1996-10-09. The listed applicant is Skil-Care Corp.. The 510(k) number is K963460.

When did ROLL BELT receive FDA 510(k) clearance?

ROLL BELT received FDA 510(k) clearance on 1996-10-09, under 510(k) number K963460.

Who is the listed applicant for ROLL BELT?

The FDA 510(k) record lists Skil-Care Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROLL BELT?

The FDA product code for ROLL BELT is FMQ.

Other records listing Skil-Care Corp. 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.

K010818INFANT LIMB HOLDER, MODELS 306080 & 306081K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025K963458PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTSK963459SUPPORT VESTK963461SAFETY PONCHO/SHOULDER STRAP PONCHOK963457SLEEPER JACKET/HOUDINI SAFETY SLEEPER

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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

View on FDA Database →

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

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