Stretcher, Wheeled, Powered
A Powered Wheeled Stretcher is a motorized transport stretcher used in Physical Medicine and hospital settings to safely move patients who are unable to walk or sit, reducing the physical burden on healthcare workers during patient transport within clinical facilities. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is INK, regulated under 21 CFR 890.3690, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.
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Basic Information
- Product Code
- INK
- Device Class
- FDA class 2
- Regulation Number
- 890.3690
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152056 | Winco Model S550 Stretchair | Apr 11, 2016 | Substantially Equivalent | Winco Manufacturing, LLC |
| K140095 | PRIME ZOOM STRETCHER | May 20, 2014 | Substantially Equivalent | Stryker Corporation |
| K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | Sep 19, 2011 | Substantially Equivalent | Hill-Rom Co. |
| K110671 | WINCO STRETCHAIR | Apr 22, 2011 | Substantially Equivalent | Winco Mfg., LLC |
| K102236 | HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P | Nov 18, 2010 | Substantially Equivalent | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L |
| K091043 | POWER DRIVE CHAIR, MODEL: TMM6 | May 11, 2009 | Substantially Equivalent | Transmotion Medical, Inc. |
| K051861 | THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 | Sep 28, 2005 | Substantially Equivalent | Savion Industries, Ltd. |
| K041924 | HAUSTED POWERTRAN SERIES STRETCHER | Sep 09, 2004 | Substantially Equivalent | STERIS Corporation |
| K022309 | STRYKER POWERED WHEELED STRETCHER | Nov 08, 2002 | Substantially Equivalent | Stryker Corp. |
| K912175 | ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE | Jun 07, 1991 | Substantially Equivalent | Isotechnologies, Inc. |
| K844711 | MODELS 134, 135 & 136 TRANSFER CART/TABLE | Mar 05, 1985 | Substantially Equivalent | Tri W-G, Inc. |
| K771018 | TRANS 2000 | Jul 14, 1977 | Substantially Equivalent | Hamilton Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.