Stretcher, Hand-Carried
FDA product code FPP · Class I (low risk) · 21 CFR 880.6900 · General Hospital
39510(k) clearances
0PMA approvals
12recalls
GMP exemptexempt from GMP rules
Manufacturers
- Araluen, Inc. 3
- W. Murphy Ent., Inc. 3
- Minto Research & Development, Inc. 2
- Dyna Corp. 2
- Skedco, Inc. 2
- Prism Enterprises, Inc. 1
- Fraser Sweatman, Inc. 1
- Innovative Medical Technologies, Inc. 1
- Lifeport, Inc. 1
- Dow Cover Co., Inc. 1
- Dept. of the Army 1
- Ram Marketing, Inc. 1
- North East Technology 1
- Junkin Safety Appliance Co., Inc. 1
- Military Engineering, Inc. 1
- Brenner Metal Prod Corp. 1
- Omnium Services Partners, Inc. 1
- Australian Biomedical Corporation , Ltd. 1
- Medicon, Inc. 1
- E.M. Adams 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030283 | Baby PodFPP · Traditional | Prism Enterprises, Inc. | 04/22/2003SE |
| K942356 | MED-EVAC-4 Medical Evacuation StretcherFPP · Traditional | Montery Bay Corp. | 07/19/1994SE |
| K940130 | Stryker Model 6110 Emergency/Pole StretcherFPP · Traditional | Stryker Corp. | 03/10/1994SE |
| K940245 | Evacu-SledFPP · Traditional | Evacu Technologies, Inc. | 02/28/1994SE |
| K924275 | Restraining StretcherFPP · Traditional | Dms | 07/27/1993SE |
| K922816 | U P Custom Design, Inc. Cot Equipment CarrierFPP · Traditional | Up Custom Design, Inc. | 07/13/1993SE |
| K924669 | Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional | Ferno | 04/29/1993SE |
| K920805 | Life Lite Emergency StretcherFPP · Traditional | Design Principles, Inc. | 05/22/1992SE |
| K915874 | Basket Litter CarrierFPP · Traditional | Bradco Med , Ltd. | 05/13/1992SE |
| K914140 | Grassi Gastrojejun Tube Gastric Decomp/Jejun FeedFPP · Traditional | Bissell Medical Products, Inc. | 03/31/1992SE |
| K913520 | Evacu SledFPP · Traditional | Nexus Health Care Products , Ltd. | 12/04/1991SE |
| K911765 | Hand Carried StretcherFPP · Traditional | L.E. Phillips Career Development Center, Inc. | 06/14/1991SE |
| K904237 | Rapid Immobilization Device or R.I.D. SystemFPP · Traditional | Innovative Medical Technologies, Inc. | 05/09/1991SE |
| K910709 | Weevac TC Hand Carried Rescue StretcherFPP · Traditional | W. Murphy Ent., Inc. | 04/01/1991SE |
| K905381 | ManhandlerFPP · Traditional | Lifeport, Inc. | 03/13/1991SE |
| K904511 | Hand-Carried Stretchers/Break Away FlatFPP · Traditional | Minto Research & Development, Inc. | 10/12/1990SE |
| K904494 | Hand-Carried StretchersFPP · Traditional | Minto Research & Development, Inc. | 10/12/1990SE |
| K904261 | Litter, Nonridgid, Poleless, Nylon StretcherFPP · Traditional | Dow Cover Co., Inc. | 10/12/1990SE |
| K902474 | Weevac 1 Portable Rescue StretcherFPP · Traditional | W. Murphy Ent., Inc. | 07/24/1990SE |
| K901760 | Litter, Folding Rigid Pole, DecontaminableFPP · Traditional | Dept. of the Army | 07/10/1990SE |
| K902521 | Weevac 6 Infant Evacuation StretcherFPP · Traditional | W. Murphy Ent., Inc. | 06/22/1990SE |
| K900671 | Hare Emergency Stretcher with WheelsFPP · Traditional | Dyna Corp. | 04/23/1990SE |
| K900670 | Hare Emergency StretcherFPP · Traditional | Dyna Corp. | 04/23/1990SE |
| K896179 | Sked Flotation SystemFPP · Traditional | Skedco, Inc. | 01/11/1990SE |
| K896177 | Sked StretcherFPP · Traditional | Skedco, Inc. | 01/11/1990SE |
| K896261 | The SmithcotFPP · Traditional | Ram Marketing, Inc. | 12/22/1989SE |
| K892892 | Net Stretcher Pad (TM)FPP · Traditional | North East Technology | 11/21/1989SE |
| K871629 | Folding Litter Support, NSN6530-00-660-0034FPP · Traditional | Junkin Safety Appliance Co., Inc. | 05/06/1987SE |
| K870327 | Back Rest, Litter, NonadjustableFPP · Traditional | Military Engineering, Inc. | 02/10/1987SE |
| K863686 | Back Rest, Litter, Non-AdjustableFPP · Traditional | Brenner Metal Prod Corp. | 01/20/1987SE |
| K863511 | Immobilizing Vacuum Matress (Ivm)FPP · Traditional | Omnium Services Partners, Inc. | 09/25/1986SE |
| K851660 | Donway Lifting FrameFPP · Traditional | Australian Biomedical Corporation , Ltd. | 08/07/1985SE |
| K840034 | Vacuum Stretcher ImmobilizerFPP · Traditional | Medicon, Inc. | 02/27/1984SE |
| K831731 | Infant Evaluation CarrierFPP · Traditional | E.M. Adams | 07/18/1983SE |
| K811547 | Matelas Coquille Lattrede TassignyFPP · Traditional | Firn-France | 06/18/1981SE |
| K810868 | Araluen Head ShieldFPP · Traditional | Araluen, Inc. | 05/13/1981SE |
| K810922 | Araluen Sky Grab BridleFPP · Traditional | Araluen, Inc. | 04/29/1981SE |
| K792566 | The Araluen CarrierFPP · Traditional | Araluen, Inc. | 12/20/1979SE |
| K770911 | Medishield Jordon Lifting FrameFPP · Traditional | Fraser Sweatman, Inc. | 06/27/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0066-2017 Class II | TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Winco Mfg., LLC | 06/29/2016Terminated |
| Z-0065-2017 Class II | TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Winco Mfg., LLC | 06/29/2016Terminated |
| Z-0064-2017 Class II | TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair.…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Winco Mfg., LLC | 06/29/2016Terminated |
| Z-0943-2012 | Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE…The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone… | Stryker Medical Division of Stryker… | 10/31/2011Terminated |
| Z-3011-2011 | Stryker EMS Stair - Pro Evacuation Chair Model 6252 It Is intended to aid in the…This recall was initiated as the firm ascertained the supplier may have reworked some of the red release… | Stryker Medical Division of Stryker… | 06/28/2011Terminated |
| Z-3010-2011 | Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of…Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were… | Stryker Medical Division of Stryker… | 06/28/2011Terminated |
| Z-0149-2010 | Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport…The front of the handle may become detached from the chair, which could result in a patient fall or an… | Stryker Medical Div. of Stryker Corporation | 09/02/2009Terminated |
| Z-0148-2010 | Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251.The front of the handle may become detached from the chair, which could result in a patient fall or an… | Stryker Medical Div. of Stryker Corporation | 09/02/2009Terminated |
| Z-0650-2009 | Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport…Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or… | Stryker Medical Div. of Stryker Corporation | 11/18/2008Terminated |
| Z-0649-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport…Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or… | Stryker Medical Div. of Stryker Corporation | 11/18/2008Terminated |
| Z-0648-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or… | Stryker Medical Div. of Stryker Corporation | 11/18/2008Terminated |
| Z-0568-2010 | Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried…Possible partial board disassembly due to inadequate webbing attachment. | Paramed Systems | 10/29/2008Terminated |