Prime Series
1125-000-000C
5manufacturers in China registered for this device type
7catalogue numbers in this listing
2510(k) clearances naming this product code
16recalls on this code
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Zhangjiagang NEW Fellow MED Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Jiangsu Yongxin Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 10 |
| Jiangyin Everise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 10 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | INK |
| Device type | Stretcher, Wheeled, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140095 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Handling environment temperature -4 to 140 °F; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1125 | In distribution | |
| 1125 | In distribution | |
| 1125 | In distribution | |
| 1125 | In distribution | |
| 1125 | In distribution | |
| 1125 | In distribution | |
| 1125 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sprint 200 | L I N E T spol. s r.o. | 14 |
| Stretcher Surface | Hill-Rom de México, S. de R.L. de C.V. | 9 |
| Stretcher, Wheeled, Powered | Stryker GmbH | 4 |
| TransMotionMedical | Winco Mfg., LLC | 4 |
| Sprint 400 | L I N E T spol. s r.o. | 3 |
| Havasu | Stryker GmbH | 2 |
| Bounder Plus | 21ST Century Scientific, Inc. | 1 |
| Electric Stretcher | Hill-Rom de México, S. de R.L. de C.V. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140095 | 2014-05-20 |
| K022309 | 2002-11-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | 510(k) number | 2016-02-05 | Class II | Mixed-up of materials/components | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore i | 36 | 2016-09-06 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-07 | Class II | Component change control | Ambulance Cots may not meet crash test standard BS EN 1789 | 34 units | 2021-01-22 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 6 | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 7 | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 7 | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 26 units | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 4 | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 23 | 2013-08-28 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, o | 91 | 2013-08-28 |
| 2010-03-19 | Not classified | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | 238 | 2011-05-02 |
| 2010-03-19 | Not classified | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | 39 Stretchers | 2011-05-02 |
| 2010-03-19 | Not classified | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | 19 Stretchers | 2011-05-02 |
| 2010-03-19 | Not classified | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | 61 stretchers | 2011-05-02 |
| 2010-03-19 | Not classified | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | 4,558 Stretchers | 2011-05-02 |
| 2003-12-30 | Not classified | Other | Users may be pinched in the siderail assembly when raising or lowering the siderail. | 107 | 2004-04-15 |
| 2003-12-01 | Not classified | Other | The user may be pinched by the siderail when raising or lowering the siderail. | 3903 | 2004-04-12 |
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.