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510(k) K972123

PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 by Smith — Product Code FMQ

K972123 is an FDA 510(k) premarket notification submitted by Smith for the device "PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905". The FDA issued a decision of Substantially Equivalent on July 25, 1997. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Smith has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1997
Date Received
June 5, 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 Smith

  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K973748 — TEMPO AND TEMP H20 (March 10, 1998)
  • K971092 — QA-ES (April 23, 1997)
  • K970555 — IL0292 DP ECHOPORT (March 17, 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