Q Patch
Q Patch is a single-channel ECG recorder worn over the sternum for long-term recording in adults. It snaps onto two standard solid-gel silver/silver-chloride electrodes and stores ECG data…
Q Patch is a single-channel ECG recorder worn over the sternum for long-term recording in adults. It snaps onto two standard solid-gel silver/silver-chloride electrodes and stores ECG data for up to 15 days.
A mobile application starts or stops a session and displays device status. After recording, a computer downloader transfers stored data through USB for subsequent review in compatible software.
Listed Item
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
Recording Workflow
A nonrechargeable CR2032 battery powers the recorder and is replaced by monitoring-center technicians. The product records ECG rather than performing automated arrhythmia classification. Healthcare professionals or trained ECG technicians review the transferred recording using separate analysis and visualization tools.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| DM Systems (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Medicalgorithmics S.A., Poland |
|---|---|
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K210758 |
| Record published | 2022-06-23 |
| Record revised | 2023-01-23 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 45 °C; Storage environment temperature 10 to 30 °C; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P5HP-AA-ADS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 60 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 58 |
| Norav NR Series | Norav Medical Inc. | 56 |
| Eclipse Pro | Spacelabs Healthcare (Washington), Inc | 25 |
| Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 15 |
| Seer 1000 ECG Cable | Getemed Medizin- UND Informationstechnik AG | 12 |
| ECG Cable for Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 12 |
| Seer | Suzuken Co., Ltd. | 12 |
| H12+ | Mortara Instrument, Inc. | 10 |
| Lifecard | Spacelabs Healthcare (Washington), Inc | 10 |
| H3+ Patient Cable | Mortara Instrument, Inc. | 10 |
| Spiderview | Microport CRM SRL | 9 |
Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210758 | 2022-06-02 |
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.