Guardian
Catalogue number TGV65W, listed by Theos Medical Systems, Inc., United States, under Alarm, Conditioned Response Enuresis. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (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 |
|---|---|---|---|---|
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Foshan RM Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
| Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
Record
| Listed by | Theos Medical Systems, Inc., United States |
|---|---|
| FDA product code | KPN |
| Device type | Alarm, Conditioned Response Enuresis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.2040 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TGV65W | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pjama | Pjama AB | 32 |
| Malem | Malem Medical Ltd | 22 |
| Chummie | Theos Medical Systems, Inc. | 15 |
| Tena | Essity Hygiene and Health AB | 11 |
| WatchCare | Hill-ROM, Inc. | 4 |
| Shield | Theos Medical Systems, Inc. | 4 |
| SIM™ tablet accessories | Simavita (Aust) PTY Ltd | 4 |
| SIM™ kit | Simavita (Aust) PTY Ltd | 4 |
| SIM pod kit | Simavita (Aust) PTY Ltd | 4 |
| DryEasy | Marvelworks Ltd. | 2 |
| Kateway | Kateway Limited | 2 |
| Fitright | Medline Industries, Inc. | 2 |
Showing 12 of 49. All products under Alarm, Conditioned Response Enuresis
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.