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510(k) K991591

BIOTHANE PATIENT RESTRAINT by Bioplastics — Product Code FMQ

K991591 is an FDA 510(k) premarket notification submitted by Bioplastics for the device "BIOTHANE PATIENT RESTRAINT". The FDA issued a decision of Substantially Equivalent on July 29, 1999. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1999
Date Received
May 7, 1999
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 for product code FMQ

  • K110377 — PROTECTIVE RESTRAINT (April 25, 2011)
  • 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)
  • 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