Lumex
Patriot LX Homecare Bed
19manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (5), Jiangsu (4), Guangdong (4). 3 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 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Yingkou Henyi Flow Control Inc. | Yingkou | Liaoning | Contract manufacturer | 5 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Zhejiang Mateside Medical Devices Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 21 |
| Foshan Suncare Medical Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 20 |
| Hebei Junlaole Medical Technology Co., Ltd. | Hengshui | Hebei | Manufacturer | 15 |
| Shenyang Henyi Enterprise Co., Ltd. | Shenyang | Liaoning | Contract manufacturer | 11 |
| Ningbo Kangmailong Medical Apparatus Co., Ltd. | Cixi City, Ningbo | Zhejiang | Contract manufacturer | 10 |
| Greatch Technology (Hebei) Co., Ltd. | Hengshui | Hebei | Manufacturer | 8 |
Showing 12 of 19. All 19 manufacturers in China registered for Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Record
| Listed by | GF Health Products, Inc, United States |
|---|---|
| FDA product code | LLI |
| Device type | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-31 |
| Record revised | 2025-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-11-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US0468-PKG | In distribution | |
| US0218-PKG | In distribution | |
| US0208 | In distribution | |
| US0458 | In distribution | |
| US6000 | Withdrawn | |
| US5000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transfer Master | GF Health Products, Inc | 35 |
| Craftmatic Model 1 Base | Craftmatic Industries, Inc. | 14 |
| sentida 03 | L I N E T spol. s r.o. | 10 |
| Medline | Medline Industries, Inc. | 7 |
| Cosyfit Long/Wide | Safespaces (Cornholme) Ltd | 4 |
| Cosyfit standard/Extra Wide | Safespaces (Cornholme) Ltd | 4 |
| Invacare® IVC™ Series Homecare BED | Invacare GmbH | 4 |
| Cosyfit Long/Extra Wide | Safespaces (Cornholme) Ltd | 4 |
| Cosyfit Hi-Lo Profiling Standard | Safespaces (Cornholme) Ltd | 4 |
| Cosyfit Hi-Lo Standard/Wide | Safespaces (Cornholme) Ltd | 4 |
| Cosyfit Long | Safespaces (Cornholme) Ltd | 4 |
| Cosyfit standard | Safespaces (Cornholme) Ltd | 4 |
Showing 12 of 55. All products under Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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 |
|---|---|---|---|---|---|
| 2012-04-17 | Not classified | Component change control | GF Health Products, Inc., is conducting a recall on the Lumex Patriot Full Electric Homecare “Bed Ends” manufactured 3/27/09, 5/9/09, 5/30/09 and 6/20/09. The supplier deviated from the print specifications of a machined pin to a sheared p | 3095 pairs of bed ends | 2013-07-15 |
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.