510(k) K112502
- Device
- PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
- Applicant
- HILL-ROM CO.
- 510(k) number
- K112502
- Product code
- INK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-19
- Date received
- 2011-08-30
- Regulation
- 890.3690
- Classification name
- Stretcher, Wheeled, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CHAD HODSON
- Address
- 1069 State Rt. 46 E. Batesville IN US 47006 47006
FDA Registration Numbers#
- 3007583774
- 3008042739
- 3006975482
- 3011647337
- 3005070829
- 3030412764
- 3006697241
- 9681454
- 3018269545
- 3008058231
- 1831750
- 1824206
- 3042970964
- 3004198457
- 2031966
- 2027797
- 1027229
- 3013524663
Source Documents#
Other 510(k) Records For Product Code INK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152056 | Winco Model S550 Stretchair | Winco Manufacturing, LLC | 2016-04-11 |
| K140095 | PRIME ZOOM STRETCHER | Stryker Corporation | 2014-05-20 |
| K110671 | WINCO STRETCHAIR | Winco Mfg., LLC | 2011-04-22 |
| K102236 | HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 2010-11-18 |
| K091043 | POWER DRIVE CHAIR, MODEL: TMM6 | Transmotion Medical, Inc. | 2009-05-11 |
| K051861 | THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 | Savion Industries, Ltd. | 2005-09-28 |
| K041924 | HAUSTED POWERTRAN SERIES STRETCHER | STERIS Corporation | 2004-09-09 |
| K022309 | STRYKER POWERED WHEELED STRETCHER | Stryker Corp. | 2002-11-08 |
| K912175 | ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE | Isotechnologies, Inc. | 1991-06-07 |
| K844711 | MODELS 134, 135 & 136 TRANSFER CART/TABLE | Tri W-G, Inc. | 1985-03-05 |
| K771018 | TRANS 2000 | Hamilton Industries, Inc. | 1977-07-14 |
Legacy Summary#
summary
FDA Review#
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