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510(k) K812477

ARM SLING, POUCH TYPE by Maddak, Inc. — Product Code ILI

K812477 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "ARM SLING, POUCH TYPE". The FDA issued a decision of Substantially Equivalent on September 14, 1981. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1981
Date Received
August 31, 1981
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 Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

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)
  • K823810 — A.C. SPLINT (January 14, 1983)
  • K823808 — VARIOUS ARM SLING (January 14, 1983)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823162 — UNIVERSAL SLING, SLING & SWATHE (November 10, 1982)
  • K820590 — ORTHOPEDIC SOFT GOODS (March 26, 1982)
  • K812480 — LIMB HOLDER ARM SLING (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)

FDA data resources