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FDA 510(k)

PROTECTIVE RESTRAINT

K-Number: K963492 · 1996-11-12

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1996-11-12
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECTIVE RESTRAINT is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1996-11-12 under 510(k) number K963492. 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 RESTRAINT is a medical device that received FDA 510(k) clearance on 1996-11-12. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K963492.

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

PROTECTIVE RESTRAINT received FDA 510(k) clearance on 1996-11-12, under 510(k) number K963492.

Who is the listed applicant for PROTECTIVE RESTRAINT?

The FDA 510(k) record lists Smith and Nephew Donjoy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTIVE RESTRAINT?

The FDA product code for PROTECTIVE RESTRAINT is FMQ.

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Other records listing Smith and Nephew Donjoy, 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.

K970051MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICEK963489WHEEL CHAIR ACCESSORYK963490PROTECTIVE RESTRAINT - BELTSK962462MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATORK955057MODEL 1100 COLD THERAPY DEVICEK951350MUSCLESENSE ELECTROMYOGRAPHY DEVICE

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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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