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510(k) K821582

WARM'N FORM SPORTS SUPPORTS by Jerome Medical — Product Code IQI

K821582 is an FDA 510(k) premarket notification submitted by Jerome Medical for the device "WARM'N FORM SPORTS SUPPORTS". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Jerome Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 28, 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 Jerome Medical

  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K930021 — J TONGS (December 6, 1995)
  • K930153 — SYSTEM III HALO RING (August 6, 1993)
  • K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE (September 30, 1988)
  • K870053 — TORQUEDRIVER WRENCH (March 11, 1987)
  • K864969 — JMS HALO APPLICATION TRAY (February 18, 1987)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K822780 — CERVICAL BRACE (October 6, 1982)

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