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FDA 510(k)

PROTECTIVE RESTRAINT

K-Number: K110377 · 2011-04-25

ApplicantMedi-Tech Intl. Corp.
Decision Date2011-04-25
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 Medi-Tech Intl. Corp.. It received FDA 510(k) clearance on 2011-04-25 under 510(k) number K110377. 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 2011-04-25. The listed applicant is Medi-Tech Intl. Corp.. The 510(k) number is K110377.

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

PROTECTIVE RESTRAINT received FDA 510(k) clearance on 2011-04-25, under 510(k) number K110377.

Who is the listed applicant for PROTECTIVE RESTRAINT?

The FDA 510(k) record lists Medi-Tech Intl. Corp. 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 Medi-Tech Intl. 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.

K002666DIAMOND ALOE VERA, STERILEK864124SPAND-GEL GRANULATED GEL

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.

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.K991591BIOTHANE PATIENT RESTRAINTBioplastics

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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