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510(k) K970273

PATIENT RESTRAINTS by Fla Orthopedics, Inc. — Product Code FMQ

K970273 is an FDA 510(k) premarket notification submitted by Fla Orthopedics, Inc. for the device "PATIENT RESTRAINTS". The FDA issued a decision of Substantially Equivalent on April 11, 1997. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Fla Orthopedics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1997
Date Received
January 23, 1997
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 Fla Orthopedics, Inc.

  • K970274 — PATIENT RESTRAINTS (April 11, 1997)
  • K970272 — PATIENT RESTRAINT (April 11, 1997)
  • K970275 — PATIENT RESTRAINTS (April 11, 1997)

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)

FDA data resources