510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800076Substantially Equivalent

Crutch Tips, Pads & Hand Grips

New World Imports, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800076 is the FDA 510(k) clearance record for CRUTCH TIPS, PADS & HAND GRIPS, a class I device, cleared for New World Imports, Inc. on under FDA product code INP (Tips And Pads, Cane, Crutch And Walker). FDA records list one 510(k) clearance for New World Imports, Inc. As of , FDA records show no recalls naming K800076.

Clearance record

Decision date
Received
(14 days to decision)
Product code
INP Tips And Pads, Cane, Crutch And Walker
Regulation
21 CFR 890.3790
Device class
Class I
Review panel
Physical Medicine
Applicant
New World Imports, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code INP

Trailing 12 months

FDA records hold no clearances under product code INP in the trailing twelve months.

FDA records show no clearances under product code INP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code INP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260