Tena
The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to…
The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems.
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 | Essity Hygiene and Health AB, Sweden |
|---|---|
| FDA product code | KPN |
| Device type | Alarm, Conditioned Response Enuresis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.2040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-27 |
| Record revised | 2018-06-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Case of 48, case of 2 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SmartCare Sensor Strip 2 | 2 | In distribution | |
| SmartCare Sensor Strip long | 2 | In distribution | |
| IDENTIFI SENSORWEAR M/R | 12 | In distribution | |
| SmartCare Sensor Strip medium | 2 | In distribution | |
| SmartCare Transmitter | In distribution | ||
| IDENTIFI SENSORWEAR L/XL | 12 | In distribution | |
| IDENTIFI LOGGER KIT | In distribution | ||
| SmartCare Sensor Strip short | 2 | In distribution | |
| SmartCare Sensor Strip 1 | 2 | In distribution | |
| SmartCare Transmitter | In distribution | ||
| SmartCare Sensor Strip 3 | 2 | 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 |
| 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 |
| Smart | Theos Medical Systems, 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.