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510(k) Data Aggregation
K Number
K110377Device Name
PROTECTIVE RESTRAINT
Manufacturer
MEDI-TECH INTL. CORP.
Date Cleared
2011-04-25
(75 days)
Product Code
FMQ, FMO
Regulation Number
880.6760Why did this record match?
Applicant Name (Manufacturer) :
MEDI-TECH INTL. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.
Device Description
The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended for medical purposes to control the movement of a patient's hand or finger movements thereby enabling examination or protection of the patient or others. Device Design Materials Used/Physical Properties: The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers. Primarily comprised of cotton and polyester material and polyester fiber filling.
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K Number
K002666Device Name
DIAMOND ALOE VERA, STERILE
Manufacturer
MEDI-TECH INTL. CORP.
Date Cleared
2001-02-27
(186 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDI-TECH INTL. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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