Icare PATIENT2
iCare PATIENT2 is a mobile application for transferring eye-pressure measurements from an iCare tonometer to the iCare CLINIC cloud service or an external system. Patients and healthcare…
iCare PATIENT2 is a mobile application for transferring eye-pressure measurements from an iCare tonometer to the iCare CLINIC cloud service or an external system. Patients and healthcare professionals use the application.
The app receives measurements through a Bluetooth connection or a USB Type-C connection between the tonometer and a mobile phone. The available transfer method depends on the phone’s operating system.
Listed Item
iCare PATIENT2 (Android version)
Measurement Results
PATIENT2 displays the eye-pressure results to support glaucoma management. The transferred measurements can be made available for further analysis in iCare CLINIC.
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Icare Finland Oy, Finland |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| Establishment | Manufacturer |
| 510(k) | K211355 |
| Record published | 2024-04-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS05 | In distribution | |
| TS05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tonometer AT 900 | Haag-Streit AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Ocu-Film® +” | Reichert Inc. | 5 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| AccuTip Cover | Accutome, Inc. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 4 |
| Applanation Tonometer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 3 |
| Icare ic200 | Icare Finland Oy | 3 |
| Marco | Takagi Seiko Co., Ltd. | 2 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
| Takagi | Takagi Seiko Co., Ltd. | 2 |
Showing 12 of 71. All products under Tonometer, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241447 | 2024-09-27 |
| K220852 | 2022-10-06 |
| K211355 | 2022-01-25 |
| K200966 | 2020-05-07 |
| K190316 | 2020-01-14 |
| K163343 | 2017-03-21 |
| K153694 | 2016-04-19 |
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.