Medline
Rail, Xtra Tall(Sold AS Pair),F/FCE Beds
95manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FNL |
| Device type | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Premarket notification | Exempt |
| Record published | 2022-03-04 |
| Record revised | 2024-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Risk of Explosion if used I presence of flammable anesthetics |
| Packaging | Pack of 2, mc of 25, mc of 100 |
| Sizes | Width 39 to 42 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FCE1232B | In distribution | ||
| FCE1232038 | In distribution | ||
| FCERSRNLATCH | In distribution | ||
| MDSLOWBED | In distribution | ||
| MDR107003L | In distribution | ||
| FCE1232ABN | In distribution | ||
| MDR107003E | In distribution | ||
| MDR620124 | In distribution | ||
| FCE1232RSR | In distribution | ||
| FCE1233002 | In distribution | ||
| MDS89694N | In distribution | ||
| FCE1232EXT | In distribution | ||
| FCE1232017 | In distribution | ||
| MDS89698N | In distribution | ||
| FCE1232BL | In distribution | ||
| MDR107003LO | In distribution | ||
| FCE42KIT | Width 42 in | In distribution | |
| MDS89697 | 2 | In distribution | |
| FCE1232RSRN | In distribution | ||
| MDR107003ELO | In distribution | ||
| FCE1232003 | In distribution | ||
| FCE1385B | In distribution | ||
| MDR610EXT | In distribution | ||
| FCE1232TPZ | In distribution | ||
| FCEQRSIDE | In distribution | ||
| MDR107002L | In distribution | ||
| FCE1232HDW | In distribution | ||
| MDR630EXTN | In distribution | ||
| MDR107002E | In distribution | ||
| MDS89697BAR | In distribution | ||
| FCE1100B | In distribution | ||
| FCE1232RSRXT | In distribution | ||
| MDRBEDEXT | In distribution | ||
| MDSLOWBASIC | In distribution | ||
| FCE39KIT | Width 39 in | In distribution | |
| FCE1232043 | 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 |
| Enterprise | Arjohuntleigh AB | 80 |
| 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 |
Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K932663 | 1993-11-30 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 373392 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 13245 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 138412 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 22565 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 35694 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-11-26 | Class I | Device Design | Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed move | 15581 units |
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.