ITJ
14 FDA 510(k) clearances · Product code
19 daysmedian time to decision
42 days90th percentile
14clearances measured
FDA profile
- Official device name
- Walker, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3825
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2021: 81 · 2022: 114 · 2023: 140 · 2024: 84 · 2025: 134 · 2026: 998
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 |
|---|---|---|
| CHILD'S WALKER (K833869) | Kaye Products, Inc. | 1983-11-29 |
| UMBRELLA WALKER (K833195) | Convaid Products, Inc. | 1983-10-27 |
| WALK N ROLL (K830784) | Meta-Morris | 1983-05-25 |
| RESI-WALKER (K830848) | Lic-Orthion | 1983-04-05 |
| RESI-WALKER (K823105) | Orthion Corp. | 1982-11-05 |
| LIGHT WEIGHT ALUMINUM WALKER (K821404) | Manuco Manufacturing Co., Inc. | 1982-05-21 |
| WALK-A-CYCLE (K820711) | Walk-A-Cycle Division | 1982-04-08 |
| WALKER/CRUTCH BAG (K811485) | Fred Sammons, Inc. | 1981-06-16 |
| DELTA ROLLING SELF-LICKING WALKER (K792064) | Staricat, Inc. | 1979-10-30 |
| WALKING AID (K790529) | Maddak, Inc. | 1979-04-03 |
| WALKING AID (K772049) | Guardian Products Co., Inc. | 1977-11-11 |
| ANIMATOR (K770417) | Kdk Medical Products | 1977-04-15 |
| WALKING AID (K770608) | Will Ross Co. | 1977-04-08 |
| MANOY WALKING AID (K770166) | Maddak, Inc. | 1977-01-28 |
Track ITJ automatically
Every clearance here is in the API, with alerts when new ones post.