Home / 510(k) Clearances / K760618

510(k) K760618

PATIENT RESTRAINT by Encompass Group, LLC — Product Code FMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1976
Date Received
September 13, 1976
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 Encompass Group, LLC

  • K203085 — NOVA Patient Warming System (November 12, 2020)
  • K982058 — ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN (January 14, 1999)
  • K982059 — ROTECNO 2000 SURGICAL GOWN (November 30, 1998)

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)
  • 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)