Sentida 5
Catalogue number 19-1119, listed by Wissner-Bosserhoff Gmbh, Germany, under Bed, Therapeutic, Ac-Powered, Adjustable Home-Use. 19 manufacturers in China are registered for this product code.
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 | Wissner-Bosserhoff Gmbh, Germany |
|---|---|
| FDA product code | LLI |
| Device type | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19-1119 | In distribution |
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 |
| Lumex | GF Health Products, Inc | 6 |
| 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 |
Showing 12 of 55. All products under Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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 |
|---|---|---|---|---|
| 2022-07-11 | Class II | Device Design | When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved. | 77 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.