Craftmatic Model 1 Base
14 catalogue numbers from 4AW532, listed by Craftmatic Industries, Inc., 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 | Craftmatic Industries, Inc. |
|---|---|
| FDA product code | LLI |
| Device type | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Premarket notification | Exempt |
| Record published | 2022-02-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Sizes | Weight 105 to 156 lb; length 74 to 84 in; width 30 to 59 in; height 5 in; depth 5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4AW532 | Weight 148 lb | In distribution |
| 4AW534 | Weight 120 lb | In distribution |
| 4AW535 | Length 80 in | In distribution |
| 4AW539 | Weight 153 lb | In distribution |
| 4AW530 | Weight 151 lb | In distribution |
| 4AW540 | Weight 105 lb | In distribution |
| 4AW533 | Weight 105 lb | In distribution |
| 4AW538 | Weight 117 lb | In distribution |
| 4AW531 | Weight 112 lb | In distribution |
| 4AW528 | Weight 120 lb | In distribution |
| 4AW541 | Weight 130 lb | In distribution |
| 4AW537 | Weight 156 lb | In distribution |
| 4AW529 | Weight 143 lb | In distribution |
| 4AW536 | Weight 148 lb | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transfer Master | GF Health Products, Inc | 35 |
| 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 |
| Cosyfit standard | Safespaces (Cornholme) Ltd | 4 |
Showing 12 of 55. All products under Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Recalls
2 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 |
|---|---|---|---|
| 2017-03-24 | Class II | Component design/selection | A potential for dual-configured beds to separate or slip away from one another. |
| 2017-03-24 | Class II | Component design/selection | A potential for dual-configured beds to separate or slip away from one another. |
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.