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510(k) K771630

LIMB RESTRAINT by Medical Restraints, Inc. — Product Code FMQ

K771630 is an FDA 510(k) premarket notification submitted by Medical Restraints, Inc. for the device "LIMB RESTRAINT". The FDA issued a decision of Substantially Equivalent on September 30, 1977. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Medical Restraints, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1977
Date Received
August 26, 1977
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 Medical Restraints, Inc.

  • K771636 — BODY RESTRAINT (September 30, 1977)
  • K771629 — HAND RESTRAINT (September 30, 1977)
  • K771715 — PELVIC WHEELCHAIR RESTRAINT (September 28, 1977)
  • K771632 — FINGER MITT RESTRAINT (September 28, 1977)
  • K771635 — FOOT ELEVATOR (September 28, 1977)
  • K771634 — VEST RESTRAINT (September 28, 1977)
  • K771676 — FOOT DROP BOOT (September 20, 1977)
  • K771631 — WHEELCHAIR SAFETY BELT (September 12, 1977)
  • K771633 — HEEL PROTECTOR (September 12, 1977)

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