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510(k) K800715

OHC DYNAMIC CLUB FOOT BRACE by Ipos Luneburg — Product Code IQI

K800715 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "OHC DYNAMIC CLUB FOOT BRACE". The FDA issued a decision of Substantially Equivalent on May 2, 1980. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Ipos Luneburg has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1980
Date Received
March 31, 1980
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 Ipos Luneburg

  • K834143 — NYLON COMPRESSION STUMP SHEATH (January 9, 1984)
  • K833868 — IPOS G.L.P. SYSTEM (November 28, 1983)
  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K802976 — CARBONACRYL (December 19, 1980)
  • K802977 — IPOCARBON STRETCH STOCKINETTE (December 19, 1980)
  • K800749 — IPOCON 7 (July 28, 1980)
  • K800716 — ORTHOTIC LEG GAIT CORRECTOR DEVICE (May 2, 1980)

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