Isansys
Data entry & local display point tablet computer, 10.1 Screen
11manufacturers in China registered for this device type
15catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan CFE Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Chero Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Hangzhou VivaLNK Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 4 |
Record
| Listed by | Isansys Lifecare, Ltd., United Kingdom |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| 510(k) | K172329 |
| Record published | 2024-04-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Carton box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lifetemp Sensor – V2 – Large | In distribution | |
| Lifetouch Sensor – Small | In distribution | |
| Lifetouch Sensor – Medium | In distribution | |
| Lifeguard Server | In distribution | |
| Lifetemp Sensor – Medium | In distribution | |
| Lifetouch Sensor – Large | In distribution | |
| Lifetemp Sensor – Small | In distribution | |
| Lifetemp Sensor – V2 – Medium | In distribution | |
| Patient Gateway T510 – 10.1 – WiFi | In distribution | |
| Lifetemp Sensor – V2 – Large | In distribution | |
| Patient Gateway T580 – 10.1 – GSM | In distribution | |
| Patient Gateway T580 – 10.1 – WiFi | In distribution | |
| Patient Gateway SM-X200 → 10.5 – WiFi | In distribution | |
| Lifetemp Sensor – Large | In distribution | |
| Patient Gateway T515 – 10.1 – GSM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Sync | Covidien LP | 29 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden Corp. | 22 |
| LifeSync | LifeSync Corporation | 18 |
| Surveyor Patient Cable | Mortara Instrument, Inc. | 18 |
| ZephyrLIFE Home | Zephyr Technology Corporation | 11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden America, Inc. | 9 |
| InTouch Health | Intouch Health, Inc. | 7 |
| UbiqVue | LifeSignals, Inc. | 6 |
| X12+ | Mortara Instrument, Inc. | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 5 |
| Ezypro ECG Recorder | Sigknow Biomedical Co., Ltd. | 3 |
| Wi-Box™ | St. Jude Medical | 3 |
Showing 12 of 211. All products under Transmitters And Receivers, Physiological Signal, Radiofrequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172329 | 2018-04-23 |
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.