Max Pulse
Max Pulse measures heart rate noninvasively using a photoelectric probe placed on the left index finger. It is intended for adults aged 18 years or older who weigh at least 100 pounds, in…
Max Pulse measures heart rate noninvasively using a photoelectric probe placed on the left index finger. It is intended for adults aged 18 years or older who weigh at least 100 pounds, in hospitals, healthcare clinics and physicians’ offices.
The device connects to a desktop or laptop computer. The operator uses the computer mouse or keyboard to enter patient information, control the system and review the resulting analysis. The optical measurement produces a pulse waveform and heart-rate output.
Professional Measurement
The system is intended for professional use. Its reusable finger sensor uses an LED and photodiode in a clip configuration, and the stated heart-rate measurement range is 30 to 240 beats per minute.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Raycome Health Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Medicore Co., Ltd., South Korea |
|---|---|
| FDA product code | JOM |
| Device type | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2780 |
| Establishment | Manufacturer |
| 510(k) | K110374 |
| Record published | 2019-03-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 0 to 80 % RH |
| Packaging | Carton of 20, carton, carton of 10, carton of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Max Pulse | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dopplex | Huntleigh Healthcare Ltd. | 16 |
| Hokanson | D. E. Hokanson, Inc. | 7 |
| Medi | Medi Manufacturing Inc | 6 |
| QuantaFlo | Semler Scientific, Inc. | 5 |
| FloChec | Semler Scientific, Inc. | 3 |
| Doppler Model 1059-C W/PPG | Parks Medical Electronics, Inc. | 2 |
| TBL-ABI | LD Technology LLC | 1 |
| SA-3000P | Medicore Co., Ltd. | 1 |
| Mesi mTABLET ABI | Mesi D.O.O. | 1 |
| Doppler Model 1050-C W/PPG | Parks Medical Electronics, Inc. | 1 |
| Doppler Model 1058-C W/PPG | Parks Medical Electronics, Inc. | 1 |
| Doppler Model 1052-C | Parks Medical Electronics, Inc. | 1 |
Showing 12 of 20. All products under Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110374 | 2011-06-13 |
| K073323 | 2007-11-29 |
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.