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510(k) K770146

SWIVEL HEAD ADJUSTABLE CRUTCH by Maddak, Inc. — Product Code IPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crutch
Device Class
Class I
Regulation Number
890.3150
Review Panel
PM
Submission Type

Other clearances by Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (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 IPR

  • K821403 — LIGHT WEIGHT ALUMINUM CRUTCHES (June 21, 1982)
  • K800237 — FOLDING CRUTCH (February 22, 1980)
  • K790557 — CRUTCH (April 3, 1979)