K1000
K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional more data than a single lead EKG. K1000 has two electrodes…
K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional more data than a single lead EKG. K1000 has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to a smartphone or tablet. K1000 is available by prescription only.
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 | AliveCor, United States |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-03-18 |
| Record revised | 2026-01-09 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 10 to 45 °C; Handling environment humidity 10 to 95 % RH; Storage environment temperature 0 to 40 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC-029 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232035 | 2024-06-07 |
| K130921 | 2014-02-06 |
| K130409 | 2013-09-06 |
| K122356 | 2012-11-19 |
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.