FPO · Stretcher, Wheeled
General Hospital · 21 CFR 880.6910 · Class 2
Overview
| Product Code | FPO |
|---|---|
| Device Name | Stretcher, Wheeled |
| Regulation | 21 CFR 880.6910 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113598 | POWER-LOAD COT FASTENER SYSTEM | Stryker Medical | Dec 20, 2011 | SESE |
| K072598 | IRSG I-MOVER FOR BEDS | International Retail Services Group, LLC | Apr 14, 2008 | SESE |
| K972528 | DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) | Dyna Corp. | Jul 28, 1997 | SESE |
| K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | International Biomedical, Inc. | Aug 7, 1996 | SESE |
| K962181 | HARE MODEL 2000 EZ LOADER MODEL 95555 | Dyna Corp. | Aug 1, 1996 | SESE |
| K961437 | WHEELED STRETCHER | Hill-Rom, Inc. | Jun 3, 1996 | SESE |
| K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | Hill-Rom, Inc. | Nov 22, 1995 | SESE |
| K946101 | EMERGENCY/ACCIDENT TROLLEY 550 | Hogan & Hartson | Feb 7, 1995 | SESE |
| K945431 | MODEL 792 CONVERGE, MODEL 793 VISION 2000 | Hausted, Inc. | Jan 25, 1995 | SESE |
| K943969 | MODEL 578 MOBILE SURGICAL STRETCHER | Hausted, Inc. | Jan 25, 1995 | SESE |
| K942948 | STRYKER POWERED STRETCHER | Stryker Corp. | Jan 24, 1995 | SESE |
| K943529 | PATIENT TROLLEY 540 | Merivaara Instrumentarium Corp. | Oct 4, 1994 | SESE |
| K943528 | PATIENT TROLLEY 545 | Merivaara Instrumentarium Corp. | Oct 4, 1994 | SESE |
| K943262 | FUTURA JUNIOR 300/310 | Merivaara Instrumentarium Corp. | Sep 29, 1994 | SESE |
| K943864 | STRYKER 8000 SURGERY STRETCHER | Stryker Medical | Aug 25, 1994 | SESE |
| K935297 | STRYKER AMBULANCE COT MODEL 6060 | Stryker Medical | Feb 18, 1994 | SESE |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Midmark Corp. | Feb 9, 1994 | SESE |
| K933060 | S-610 & 2-628 WHEELED SHOWER STRETCHERS | The Anthros Medical Group | Feb 4, 1994 | SESE |
| K933071 | STS 701 TRANSPORT STRETCHER | Wy'East Medical Corp. | Jan 26, 1994 | SESE |
| K933366 | I.V. LINK | Deville Laboratories, Inc. | Jan 10, 1994 | SESE |
Top Applicants
- Hill-Rom, Inc. — 4 clearances
- Stryker Medical — 4 clearances
- Dyna Corp. — 3 clearances
- Keymed, Inc. — 3 clearances
- Merivaara Instrumentarium Corp. — 3 clearances
