Atlas FDA

IPS

9 FDA 510(k) clearances · Product code

15 daysmedian time to decision
28 days90th percentile
9clearances measured

FDA profile

Official device name
Cane
Device class
Class I (low risk)
Regulation
21 CFR 890.3075
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2015: 22 · 2016: 21 · 2017: 17 · 2018: 13 · 2023: 18 · 2026: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CANE REACHER (K832970)Maddak, Inc.1983-09-29
WALKING CANE (K832969)Maddak, Inc.1983-09-29
LIGHT WEIGHT ALUMINUM CANES (K821402)Manuco Manufacturing Co., Inc.1982-04-21
CERSA-CANE (K790558)Maddak, Inc.1979-04-03
OFFSET ALUMINUM CANE (K790561)Maddak, Inc.1979-04-03
FOREARM-CANE (K790299)Guardian Products Co., Inc.1979-02-21
CANE/REACHER (K780085)Fred Sammons, Inc.1978-01-30
QUADRAPLEGIC WALKING AID (K772267)Med Fusion Systems, Inc.1977-12-20
UNICET I (K770529)Union Carbide Corp.1977-04-05

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