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510(k) K802673

KNEE BRACE/STABILIZER by Omni Scientific, Inc. — Product Code ITQ

K802673 is an FDA 510(k) premarket notification submitted by Omni Scientific, Inc. for the device "KNEE BRACE/STABILIZER". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code ITQ (Joint, Knee, External Brace), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 27, 1980
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 for product code ITQ

  • K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE (June 24, 1983)
  • K831310 — BRACE C.T. (May 16, 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)
  • K780892 — FRACTURE BRACING (June 13, 1978)

FDA data resources