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510(k) K823162

UNIVERSAL SLING, SLING & SWATHE by Warm & Form, Orthopedic Materials — Product Code ILI

K823162 is an FDA 510(k) premarket notification submitted by Warm & Form, Orthopedic Materials for the device "UNIVERSAL SLING, SLING & SWATHE". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. 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
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
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 ILI

  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831706 — SATO FAMILY FIRST AID KIT (June 24, 1983)
  • K823808 — VARIOUS ARM SLING (January 14, 1983)
  • K823810 — A.C. SPLINT (January 14, 1983)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K820590 — ORTHOPEDIC SOFT GOODS (March 26, 1982)
  • K812477 — ARM SLING, POUCH TYPE (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)
  • K812480 — LIMB HOLDER ARM SLING (September 14, 1981)

FDA data resources