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510(k) K822767

UNIVERSAL DYNASPLINT by Dynasplint Systems, Inc. — Product Code IQI

K822767 is an FDA 510(k) premarket notification submitted by Dynasplint Systems, Inc. for the device "UNIVERSAL DYNASPLINT". The FDA issued a decision of Substantially Equivalent on Oct 6, 1982. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Dynasplint Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 6, 1982
Date Received
Sep 14, 1982
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 Dynasplint Systems, Inc.

  • K904973 — EXTERNAL FIXATION (Feb 21, 1991)

Other clearances for product code IQI

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

FDA data resources