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510(k) K823158

RIB BELT (UNIVERSAL) by Warm & Form, Orthopedic Materials — Product Code IPX

K823158 is an FDA 510(k) premarket notification submitted by Warm & Form, Orthopedic Materials for the device "RIB BELT (UNIVERSAL)". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code IPX (Orthosis, Rib Fracture, Soft), 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
November 10, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Rib Fracture, Soft
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)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823661 — CLAVICLE SUPPORT (December 30, 1982)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823667 — CERVICAL COLLAR (December 30, 1982)

Other clearances for product code IPX

  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K803239 — SOFTGOOD PRODUCTS AND SPLINTS (January 9, 1981)

FDA data resources