28z MDA ProFlexx® Chair Cot
28Z MDA ProFlexx® Chair Cot, Red w/Tray
31manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
11recalls 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 | Ferno-Washington, Inc., United States |
|---|---|
| FDA product code | FPO |
| Device type | Stretcher, Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6910 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-22 |
| 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 |
|---|---|---|
| 0012825 | 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 |
|---|---|
| K864269 | 1986-11-13 |
| K862441 | 1986-09-12 |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2026-06-19 | Class II | Process control | Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher | 278 | |
| 2025-09-11 | Class II | Device Design | The fastening post hardware could loosen allowing the fastening post to detach from the cot | 138 units | |
| 2022-10-07 | Class II | Component design/selection | Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury | 1,922 units | |
| 2017-03-08 | Class II | Mixed-up of materials/components | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | 34 units | 2017-06-29 |
| 2015-08-03 | Class II | Device Design | Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame. | 72 units | 2016-01-20 |
| 2015-05-01 | Class II | Process control | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use. | 26 units | 2015-11-06 |
| 2014-12-03 | Class II | Mixed-up of materials/components | The wheel castor assemblies may be loosening on the stretchers. | 46 units | 2015-12-01 |
| 2008-09-03 | Not classified | Device Design | The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation. | 2,100 | 2012-09-27 |
| 2008-04-29 | Not classified | Mixed-up of materials/components | A component defect was found in corner castings of the firm’s wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated sh | 783 units | 2012-10-30 |
| 2003-03-28 | Not classified | Other | The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher. | 2188 total stretchers | 2008-10-29 |
| 2003-03-28 | Not classified | Other | The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher. | 2188 total stretchers | 2008-10-29 |
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.