Atlas FDA

INP

8 FDA 510(k) clearances · Product code

25 daysmedian time to decision
27 days90th percentile
8clearances measured

FDA profile

Official device name
Tips And Pads, Cane, Crutch And Walker
Device class
Class I (low risk)
Regulation
21 CFR 890.3790
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2007: 3 · 2011: 128 · 2012: 5 · 2013: 113 · 2014: 27 · 2015: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SURGEON'S CHOICE CRUTCH HANDLE (K831889)W.K. Wheeler, Inc.1983-07-07
PERSONAL KNEE CRUTCH PAD (K831149)Tecnol New Jersey Wound Care, Inc.1983-05-03
CRUTCH & WALKER PADS (K811493)Fred Sammons, Inc.1981-06-12
CRUTCH TIPS & GRIPS (K810650)First Industries, Inc.1981-03-26
CONPHAR CRUTCH TIPS (K803136)Conphar, Inc.1981-01-08
CONPHAR CRUTCH GRIPS (K803140)Conphar, Inc.1981-01-08
CONPHAR CRUTCH PADS (K803144)Conphar, Inc.1981-01-08
CRUTCH TIPS, PADS & HAND GRIPS (K800076)New World Imports, Inc.1980-01-28

Track INP automatically

Every clearance here is in the API, with alerts when new ones post.