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510(k) K831889

SURGEON'S CHOICE CRUTCH HANDLE by W.K. Wheeler, Inc. — Product Code INP

K831889 is an FDA 510(k) premarket notification submitted by W.K. Wheeler, Inc. for the device "SURGEON'S CHOICE CRUTCH HANDLE". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tips And Pads, Cane, Crutch And Walker
Device Class
Class I
Regulation Number
890.3790
Review Panel
PM
Submission Type

Other clearances for product code INP

  • K831149 — PERSONAL KNEE CRUTCH PAD (May 3, 1983)
  • K811493 — CRUTCH & WALKER PADS (June 12, 1981)
  • K810650 — CRUTCH TIPS & GRIPS (March 26, 1981)
  • K803140 — CONPHAR CRUTCH GRIPS (January 8, 1981)
  • K803136 — CONPHAR CRUTCH TIPS (January 8, 1981)
  • K803144 — CONPHAR CRUTCH PADS (January 8, 1981)
  • K800076 — CRUTCH TIPS, PADS & HAND GRIPS (January 28, 1980)

FDA data resources