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510(k) K831310

BRACE C.T. by Innovation Sports, Inc. — Product Code ITQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Innovation Sports, Inc.

  • K940858 — THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) (July 12, 1994)

Other clearances for product code ITQ

  • K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE (June 24, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823397 — ANATOMIC FRACTURE BRACE (November 29, 1982)
  • K823159 — DELUXE KNEE IMMOBILIZER (November 10, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)
  • K780892 — FRACTURE BRACING (June 13, 1978)