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510(k) K823663

ABDOMINAL BINDER by Warm & Form, Orthopedic Materials — Product Code KTD

K823663 is an FDA 510(k) premarket notification submitted by Warm & Form, Orthopedic Materials for the device "ABDOMINAL BINDER". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code KTD (Orthosis, Abdominal), a Class I device regulated under 21 CFR 890.3490. Warm & Form, Orthopedic Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Abdominal
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

  • K830245 — HEAD HALTER (March 9, 1983)
  • K830244 — TRACTION ACCESSORIES (March 9, 1983)
  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K830246 — CAST SHOE, CAST BOOT (February 18, 1983)
  • K823661 — CLAVICLE SUPPORT (December 30, 1982)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823667 — CERVICAL COLLAR (December 30, 1982)

Other clearances for product code KTD

  • K823164 — ABDOMINAL BINDER (November 16, 1982)
  • K780229 — ABDOMINAL BELT (March 2, 1978)

FDA data resources