Winco Model S550 Stretchair
FDA 510(k) clearance K152056 · decided 2016-04-11
Clearance details
- K-number
- K152056
- Device name
- Winco Model S550 Stretchair
- Applicant
- Winco Manufacturing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-07-24
- Decision date
- 2016-04-11
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- INK
- Device class
- 2
- Regulation number
- 890.3690
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Ocala, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.