PRIME ZOOM STRETCHER
FDA 510(k) clearance K140095 · decided 2014-05-20
Clearance details
- K-number
- K140095
- Device name
- PRIME ZOOM STRETCHER
- Applicant
- Stryker Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-01-14
- Decision date
- 2014-05-20
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- INK
- Device class
- 2
- Regulation number
- 890.3690
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Portage, MI, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| Winco Model S550 Stretchair (K152056) | Winco Manufacturing, LLC | 2016-04-11 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005) | Stryker Corporation | 2016-08-09 |
| SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004) | Stryker Corporation | 2007-09-28 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003) | Stryker Corporation | 2002-12-31 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002) | Stryker Corporation | 1998-06-04 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001) | Stryker Corporation | 1998-06-04 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053) | Stryker Corporation | 1997-06-19 |