Prime
4 catalogue numbers from 1115MHT1, listed by Stryker GmbH, Switzerland, under Stretcher, Wheeled. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Hebei (7), Guangdong (6). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
| Foshan Fuzikon Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 21 |
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
Showing 12 of 31. All 31 manufacturers in China registered for Stretcher, Wheeled
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FPO |
| Device type | Stretcher, Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6910 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Handling environment temperature -4 to 140 °F; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1115MHT1 | In distribution | |
| 1115EHT2 | In distribution | |
| 1115EHT1 | In distribution | |
| 1115MHT2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 51 |
| Stretcher, Wheeled | Gendron, Inc. | 40 |
| Stretcher, Wheeled | Stryker GmbH | 35 |
| Havasu | Stryker GmbH | 29 |
| MJM 900 Series Gurney | M J M International Corporation | 27 |
| Sprint 100 | L I N E T spol. s r.o. | 27 |
| Hausted | GF Health Products, Inc | 24 |
| Mondial® Monobloc | Ferno-Washington, Inc. | 24 |
| Mondial® Transporter | Ferno-Washington, Inc. | 20 |
| Prime Series | Stryker GmbH | 18 |
| Pedigo Products, Inc. | Pedigo Products, Inc. | 15 |
| Zephyr Patient Stretcher | Diacor, Inc. | 14 |
Showing 12 of 182. All products under Stretcher, Wheeled
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113598 | 2011-12-20 |
| K942948 | 1995-01-24 |
| K943864 | 1994-08-25 |
| K935297 | 1994-02-18 |
| K920704 | 1992-03-23 |
Recalls
14 of these are 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 |
|---|---|---|---|---|---|
| 2023-05-24 | Class II | Process control | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. | 1,980 cots | |
| 2023-02-01 | Class II | Under Investigation by firm | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloadi | 4 units | |
| 2022-11-11 | Class II | Under Investigation by firm | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. | 465 (403 US; 62 OUS) | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 1 unit | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 3 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 3 units | |
| 2018-11-20 | Class II | Under Investigation by firm | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | 3285 | 2020-07-09 |
| 2018-03-12 | Class II | Nonconforming Material/Component | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | 4724 | 2020-05-12 |
| 2018-03-09 | Class II | Labeling Change Control | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. | 59 | 2019-04-09 |
| 2018-03-09 | Class II | Labeling Change Control | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. | 3 | 2019-04-09 |
| 2016-11-08 | Class II | Under Investigation by firm | Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back duri | 749 units | 2018-01-16 |
| 2016-05-05 | Class II | Vendor change control | Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had | 770 | 2017-09-18 |
| 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 |
| 2012-10-11 | Class II | Component design/selection | Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted. | 24 | 2013-08-30 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the asse | 6 | 2013-08-29 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the asse | 80 | 2013-08-29 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the asse | 10 | 2013-08-29 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the asse | 5 | 2013-08-29 |
| 2011-07-19 | Not classified | Nonconforming Material/Component | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the asse | 11 | 2013-08-29 |
| 2010-05-15 | Not classified | Device Design | The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures. | 7,314 | 2012-02-07 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 4736 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 75 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 1061 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 241 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 490 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 1213 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 8825 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 196 | 2010-10-29 |
| 2009-08-10 | Not classified | Nonconforming Material/Component | The brake/steer pedal may seize, resulting in the brakes not working. | 970 | 2010-10-29 |
| 2009-02-27 | Not classified | Device Design | The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler. | 3607 | 2011-04-25 |
| 2009-02-27 | Not classified | Device Design | The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler. | 38 | 2011-04-25 |
| 2007-05-07 | Not classified | Other | The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists. | 1,048 (1009 in the U.S. plus 39 international) | 2008-06-11 |
| 2006-08-29 | Not classified | Other | The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out. | 1,841 cots (44 foreign) | 2007-04-18 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 2010-10-27 |
| 2004-11-15 | Not classified | Component change control | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. | 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.