Enterprise
Medical Bed - Enterprise - E9800X - with Indigo powered drive.
95manufacturers in China registered for this device type
80catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (32), Jiangsu (20), Hebei (11). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Genteel Homecare Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 12 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Jiaxing Kalanchoe Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 8 |
| Jiangmen Jia Mei Medical Products Co., Ltd. | Heshan | Guangdong | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 95. All 95 manufacturers in China registered for Bed, Ac-Powered Adjustable Hospital
Record
| Listed by | Arjohuntleigh AB, Sweden |
|---|---|
| FDA product code | FNL |
| Device type | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-17 |
| Record revised | 2024-10-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9611AF111BCUSB | In distribution | |
| 9812HP111BCUSB | In distribution | |
| 9818D2111BCUSD | In distribution | |
| 9815A2111BCUSD | In distribution | |
| 9812DC101ADUSA | In distribution | |
| 9611AE111DCUSB | In distribution | |
| 9814DF111BCUSB | In distribution | |
| 9718D2111BCUSD | In distribution | |
| 9611AF101DCUSB | In distribution | |
| 9811AF101BGUSB | In distribution | |
| 9711AF111BCUSB | In distribution | |
| 9612DC101AFUSB | In distribution | |
| 9813GF111BCUSB | In distribution | |
| 9612CF101BCUSB | In distribution | |
| 9614DF111BCUSB | In distribution | |
| 9712HF111BCUSB | In distribution | |
| 9711DC101ADUSA | In distribution | |
| 9714EF111BCUSB | In distribution | |
| 9712DC101ADUSB | In distribution | |
| 9811BF101BGUSB | In distribution | |
| 9615A2111BCUSD | In distribution | |
| 9714DF111BCUSB | In distribution | |
| 9612HF111BCUSB | In distribution | |
| 9713GF111BCUSB | In distribution | |
| 9712CC101ADUSB | In distribution | |
| 9611FF111BCUSB | In distribution | |
| 9813BF101BGUSB | In distribution | |
| 9712DC101ADUSA | In distribution | |
| 9814EF111BCUSB | In distribution | |
| 9612CF111BCUSB | In distribution | |
| 9811AC101ADUSA | In distribution | |
| 9611AE101BCUSB | In distribution | |
| 9611DC101ADUSA | In distribution | |
| 9818D2101BCUSD | In distribution | |
| 9812DC101AFUSB | In distribution | |
| 9721DC101ADUSA | In distribution | |
| 9821AC111ABUSA | In distribution | |
| 9618D2111BCUSD | In distribution | |
| 9712CC101ADUSA | In distribution | |
| 9811CF101BGUSB | In distribution | |
| 9814DF111DCUSB | In distribution | |
| 9613BF111BCUSB | In distribution | |
| 9811BC111BEUSB | In distribution | |
| 9714DF101BCUSB | In distribution | |
| 9614DF101BCUSB | In distribution | |
| 9814ME101BAUSA | In distribution | |
| 9812CF111DCUSB | In distribution | |
| 9821DC101ADUSA | In distribution | |
| 9814DF101BCUSB | In distribution | |
| 9712DC101AFUSB | In distribution | |
| 9812CF111BCUSB | In distribution | |
| 9811AF111BCUSB | In distribution | |
| 9814DE101BCUSB | In distribution | |
| 9611AF101BCUSB | In distribution | |
| 9814DP111DAUSB | In distribution | |
| 9715A2111BCUSD | In distribution | |
| 9712CF111BCUSB | In distribution | |
| 9811DC101ADUSA | In distribution | |
| 9611BF101BCUSB | In distribution | |
| 9612BC101AFUSB | In distribution | |
| 9614EF111BCUSB | In distribution | |
| 9812DC101ADUSB | In distribution | |
| 9811BF101BCUSB | In distribution | |
| 9813BF111BCUSB | In distribution | |
| 9713BF111BCUSB | In distribution | |
| 9814EP111DAUSB | In distribution | |
| 9611AC101ADUSA | In distribution | |
| 9612DC101ADUSA | In distribution | |
| 9811DF101BGUSB | In distribution | |
| 9611BC101ADUSA | In distribution | |
| 9611AE101DCUSB | In distribution | |
| 9711AC101ADUSA | In distribution | |
| 9811AF101BCUSB | In distribution | |
| 9811FF111BCUSB | In distribution | |
| 9611AE111BCUSB | In distribution | |
| 9613GF111BCUSB | In distribution | |
| 9812HF111BCUSB | In distribution | |
| 9711FF111BCUSB | In distribution | |
| 9814DF101DCUSB | In distribution | |
| 9612DC101ADUSB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drive | Drive DeVilbiss Healthcare | 190 |
| Electrical Hospital Bed | Paramount BED Co., Ltd. | 164 |
| MC Healthcare | Span-America Medical Systems, Inc. | 160 |
| NOA Medical Industries, Inc. | Hoffmann NOA Medical Industries, LLC | 99 |
| Posey | Posey Products, LLC | 95 |
| Drivemedical | Drive DeVilbiss Healthcare | 94 |
| silverfox | Silverfox Corporation Limited | 77 |
| Electrical Hospital Bed with Digital Scale | Paramount BED Co., Ltd. | 70 |
| Basic American Medical Products | GF Health Products, Inc | 66 |
| Bed, Ac-Powered Adjustable Hospital | Gendron, Inc. | 50 |
| Accessories | Joerns Healthcare | 43 |
| WeCare Response Bed | Joerns Healthcare | 42 |
Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital
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 |
|---|---|---|---|---|---|
| 2014-03-17 | Class II | Labeling design | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. | 1,695 beds (worldwide) | 2018-02-14 |
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.