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510(k) K831615

DROP FOOT BRACE by Edward Dilauro, Jr. — Product Code IQI

K831615 is an FDA 510(k) premarket notification submitted by Edward Dilauro, Jr. for the device "DROP FOOT BRACE". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
May 19, 1983
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 for product code IQI

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  • 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)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)
  • K823160 — ROTATION BOOT (November 10, 1982)

FDA data resources