Monitor, Bed Patient
Sensormat, Chair-Check, 14 Foot Cord, 30 DAY
14manufacturers in China registered for this device type
10catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Hebei (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Perth Electronic Plastic Limited Company | Dongguan | Guangdong | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Zhongshan Saxin Electric Heating Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 27 |
| Foshan Fuzikon Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 21 |
| Hebei Healthplus Medical Device Co Ltd | Handan | Hebei | Manufacturer | 18 |
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Shenzhen Giftshine Technology Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yingkou Henyi Flow Control Inc. | Yingkou | Liaoning | Contract manufacturer | 5 |
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Monitor, Bed Patient
Record
| Listed by | Sterilmed, Inc., United States |
|---|---|
| FDA product code | KMI |
| Device type | Monitor, Bed Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2400 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-18 |
| Record revised | 2025-07-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BED73015 | Withdrawn | |
| POS8283 | Withdrawn | |
| BED73001 | Withdrawn | |
| POS8309EL | Withdrawn | |
| BED73010 | Withdrawn | |
| POS8309 | Withdrawn | |
| BED74011 | Withdrawn | |
| BED73000 | Withdrawn | |
| BED74010 | Withdrawn | |
| BED74000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Caregiver | Smart Caregiver Corporation | 442 |
| Posey | Posey Products, LLC | 95 |
| Fall Guardian | Smart Caregiver Corporation | 69 |
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Posey | Tidi Products, LLC | 17 |
| Parasol Patient Fall Prevention System | Parasol Medical | 17 |
| Monitor, Bed Patient | Stryker Sustainability Solutions | 13 |
| Medline | Medline Industries, Inc. | 12 |
| McKesson | Mckesson Medical-Surgical Inc. | 11 |
| Parasol Wireless Patient Fall Prevention System | Parasol Medical | 11 |
| Drivemedical | Drive DeVilbiss Healthcare | 10 |
| Fall monitor | Securitas Healthcare LLC | 9 |
Showing 12 of 251. All products under Monitor, Bed Patient
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 |
|---|---|---|---|---|---|
| 2008-08-08 | Not classified | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on o | 352 | 2011-04-26 |
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.