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510(k) K874502

GAIT-AID ORTHOPEDIC INSOLE by Gait-Aid, Inc. — Product Code IQI

K874502 is an FDA 510(k) premarket notification submitted by Gait-Aid, Inc. for the device "GAIT-AID ORTHOPEDIC INSOLE". The FDA issued a decision of Substantially Equivalent on November 30, 1987. 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
November 30, 1987
Date Received
November 2, 1987
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

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  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • 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)
  • K823160 — ROTATION BOOT (November 10, 1982)

FDA data resources