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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 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.