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510(k) K823166

PELVIC TRACTION BELT by Warm & Form, Orthopedic Materials — Product Code ILZ

K823166 is an FDA 510(k) premarket notification submitted by Warm & Form, Orthopedic Materials for the device "PELVIC TRACTION BELT". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925. 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
Accessories, Traction
Device Class
Class I
Regulation Number
890.5925
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)
  • K823663 — ABDOMINAL BINDER (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 ILZ

  • K921711 — FLEXION DISTRATION SUPPORT (July 13, 1992)
  • K895382 — VIBRA-TRAC TRACTION TABLE (October 16, 1989)
  • K884340 — AMX-110, AMX-II AND AMX-III (January 24, 1989)
  • K852398 — VECTOR BAR SUSPENSION/TRACTION UNIT (August 12, 1985)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K831135 — SAUNDERS #7080 CERVICAL TRACTION SYS (June 24, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)
  • K820663 — BOGER AUTO-TRACTION DEVICE (May 3, 1982)
  • K791808 — CERVI-TRAC (October 1, 1979)

FDA data resources