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510(k) K982178

VAGABOND SOFT RESTRAINT SYSTEM by Emergent Innovations, Ltd. — Product Code FMQ

K982178 is an FDA 510(k) premarket notification submitted by Emergent Innovations, Ltd. for the device "VAGABOND SOFT RESTRAINT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 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
January 26, 1999
Date Received
June 22, 1998
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)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 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