Kardioscreen
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is…
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional’s facility, clinic, physician’s office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis. Senior Virtual Health Device Details KS-A00104,KS-A00110,KS-A00111,KS-A00112,KS-A00115,KS-A00117,KS-A00122,KS-A00131,KS-A00133,KS-A00136,KS-A00138,KS-A00139,KS-A00142,KS-A00145,KS-A00148,KS-A00149,KS-A00150 KS Converter Details KS-CN-A00104,KS-CN-A00110,KS-CN-A00111,KS-CN-A00112,KS-CN-A00115,KS-CN-A00117,KS-CN-A00122,KS-CN-A00131,KS-CN-A00133,KS-CN-A00136,KS-CN-A00138,KS-CN-A00139,KS-CN-A00142,KS-CN-A00145,KS-CS-A00148,KS-CN-A00149,KS-CN-A00150 Cable Details CMP220113-003 202201130002,CMP220113-003 202201130017,CMP220110-004 202201140008,CMP220110-004 202201140015,CMP220113-003 202201130026,CMP220113-003 202201130009,CMP220110-004 202201140023,CMP220113-003 202201130021,CMP220113-003 202201130022,CMP220113-003 202201130004,CMP220110-004 202201140018,CMP220113-003 202201130018,CMP220113-003 202201130010,CMP220110-004 202201140033,CMP220110-004 202201140027,CMP220113-003 202201130024,CMP220113-003 202201130001
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 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 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Imedrix Inc. |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| 510(k) | K191692 |
| Record published | 2024-01-11 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1612A-CL | 17 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
Showing 12 of 177. All products under Electrocardiograph
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.