Cassette Holder
Catalogue number P279AT, listed by Hill-ROM, Inc., United States, under Stretcher, Wheeled. 31 manufacturers in China are registered for this product 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 | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | FPO |
| Device type | Stretcher, Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-14 |
| Record revised | 2022-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P279AT | 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 |
|---|---|
| K961437 | 1996-06-03 |
| K952447 | 1995-11-22 |
| K922809 | 1993-03-31 |
| K922808 | 1993-03-31 |
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 |
|---|---|---|---|---|---|
| 2008-04-03 | Not classified | Device Design | The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay t | 564 | 2009-12-29 |
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.