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12 FDA 510(k) clearances · Product code
83 daysmedian time to decision
126 days90th percentile
12clearances measured
FDA profile
- Official device name
- Stretcher, Wheeled, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3690
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 114 · 2022: 93 · 2023: 147 · 2024: 179 · 2025: 104 · 2026: 29
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 |
|---|---|---|
| Winco Model S550 Stretchair (K152056) | Winco Manufacturing, LLC | 2016-04-11 |
| PRIME ZOOM STRETCHER (K140095) | Stryker Corporation | 2014-05-20 |
| PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (K112502) | Hill-Rom Co. | 2011-09-19 |
| WINCO STRETCHAIR (K110671) | Winco Mfg., LLC | 2011-04-22 |
| HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (K102236) | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 2010-11-18 |
| POWER DRIVE CHAIR, MODEL: TMM6 (K091043) | Transmotion Medical, Inc. | 2009-05-11 |
| THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 (K051861) | Savion Industries, Ltd. | 2005-09-28 |
| HAUSTED POWERTRAN SERIES STRETCHER (K041924) | STERIS Corporation | 2004-09-09 |
| STRYKER POWERED WHEELED STRETCHER (K022309) | Stryker Corp. | 2002-11-08 |
| ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (K912175) | Isotechnologies, Inc. | 1991-06-07 |
| MODELS 134, 135 & 136 TRANSFER CART/TABLE (K844711) | Tri W-G, Inc. | 1985-03-05 |
| TRANS 2000 (K771018) | Hamilton Industries, Inc. | 1977-07-14 |
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Every clearance here is in the API, with alerts when new ones post.