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510(k) K771676

FOOT DROP BOOT by Medical Restraints, Inc. — Product Code IQI

K771676 is an FDA 510(k) premarket notification submitted by Medical Restraints, Inc. for the device "FOOT DROP BOOT". The FDA issued a decision of Substantially Equivalent on September 20, 1977. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Medical Restraints, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
September 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Medical Restraints, Inc.

  • K771630 — LIMB RESTRAINT (September 30, 1977)
  • 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)
  • K771633 — HEEL PROTECTOR (September 12, 1977)
  • K771631 — WHEELCHAIR SAFETY BELT (September 12, 1977)

Other clearances for product code IQI

  • K143458 — Neurosplint (August 13, 2015)
  • K052771 — SENSOR WALK (May 3, 2006)
  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)
  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831615 — DROP FOOT BRACE (June 15, 1983)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)

FDA data resources