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510(k) K110377

PROTECTIVE RESTRAINT by Medi-Tech Intl. Corp. — Product Code FMQ

K110377 is an FDA 510(k) premarket notification submitted by Medi-Tech Intl. Corp. for the device "PROTECTIVE RESTRAINT". The FDA issued a decision of Substantially Equivalent on April 25, 2011. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Medi-Tech Intl. Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2011
Date Received
February 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Protective
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Other clearances by Medi-Tech Intl. Corp.

  • K002666 — DIAMOND ALOE VERA, STERILE (February 27, 2001)
  • K864124 — SPAND-GEL GRANULATED GEL (November 26, 1986)

Other clearances for product code FMQ

  • K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (February 13, 2009)
  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)
  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 1999)
  • K982178 — VAGABOND SOFT RESTRAINT SYSTEM (January 26, 1999)
  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K972446 — PEDO CUSH PEDO CUDDLE (November 13, 1997)
  • K972046 — FULL BODY RESTRAINT SYSTEM (August 15, 1997)

FDA data resources