Stretcher, Hand-Carried
2 catalogue numbers from 6376, listed by Stryker GmbH, Switzerland, under Stretcher, Hand-Carried. 51 manufacturers in China are registered for this product code.
51manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (20), Guangdong (11), Zhejiang (7). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Hubei Yinkang Medical Equipment Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| U.S. Pacific Nonwovens Technology (Dongguan) Ltd | Dongguan | Guangdong | Contract manufacturer | 6 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 51. All 51 manufacturers in China registered for Stretcher, Hand-Carried
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FPP |
| Device type | Stretcher, Hand-Carried |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6900 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-15 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6376 | In distribution | |
| 6254 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 51 |
| Spencer | Spencer Italia SRL | 16 |
| RED Leaf | Jiangsu Rixin Medical Equipment Co., Ltd. | 13 |
| MedSource Spine Board | Medsource International, LLC | 13 |
| MedSource Stretcher | Medsource International, LLC | 12 |
| MedSource Stair Chair | Medsource International, LLC | 9 |
| XtractSR | T.S.G. Associates LLP | 9 |
| BabyPod | Advanced Healthcare Ltd. | 7 |
| Rhino Rescue | Wuxi Emsrun Technology Co., Ltd. | 5 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| MedSource Scoop Stretcher | Medsource International, LLC | 4 |
| MedSource Immobilization Board | Medsource International, LLC | 4 |
Showing 12 of 189. All products under Stretcher, Hand-Carried
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940130 | 1994-03-10 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-10-31 | Not classified | Mixed-up of materials/components | The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use. | 3 units | 2013-08-28 |
| 2011-06-28 | Not classified | Nonconforming Material/Component | This recall was initiated as the firm ascertained the supplier may have reworked some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011. The rework subjected the parts to excessive heat and as | 214 | 2013-08-29 |
| 2011-06-28 | Not classified | Nonconforming Material/Component | Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the relea | 220 | 2013-08-29 |
| 2009-09-02 | Not classified | Device Design | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. | 165 | 2011-02-16 |
| 2009-09-02 | Not classified | Device Design | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. | 65 | 2011-02-16 |
| 2008-11-18 | Not classified | Process control | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation. | 6 | 2010-10-27 |
| 2008-11-18 | Not classified | Process control | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation. | 105 | 2010-10-27 |
| 2008-11-18 | Not classified | Process control | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation. | 102 | 2010-10-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.