VitaloJAK
Vitalograph Model 7100 VitaloJAK is a non-invasive, battery-operated device for acquiring, recording and storing ambulatory cough sounds. The filing specifies recording periods of up to 24…
Vitalograph Model 7100 VitaloJAK is a non-invasive, battery-operated device for acquiring, recording and storing ambulatory cough sounds. The filing specifies recording periods of up to 24 hours.
Recorded data are stored on a removable memory card. The FDA filing describes later playback, review and analysis of cough sounds on a Windows-based PC.
Listed Item
Base VITALOJAK INTERNATIONAL WEST(1)
Recording and Review
The filing states that the device itself is not diagnostic. It says respiratory data are reviewed after the memory card is removed and transferred to a PC, where the user identifies each coughing incident.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (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 |
| Shenzhen Creative Industry Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Biox Instruments Co Ltd | Wuxi | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Vitalograph Ireland Ltd., Ireland |
|---|---|
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K110525 |
| Record published | 2021-06-18 |
| Record revised | 2019-11-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7100 | In distribution | |
| 7100 | In distribution | |
| 7100 | In distribution | |
| 7100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 33 |
| Matrix Wearable | Global Instrumentation, LLC | 12 |
| CardioSTAT | Icentia Inc | 6 |
| Holter ECG and ABP System | Edan Instruments, Inc. | 5 |
| Epatch Sensor | Braemar Manufacturing, LLC | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 4 |
| Nuubo System | Smart Solutions Technologies SL | 4 |
| Care Assist | Philips Medizin Systeme Böblingen GmbH | 4 |
| AT-Patch | ATsens Co., Ltd. | 3 |
| Cuff ABPMpro without ECG | Somnomedics AG | 3 |
| Vasomedical-Biox™ Arcs S/W Dongle – Mini 1200/1201 2 & 3 CH ECG | Vasomedical, Inc. | 3 |
| ECG Leadwire Set for CM 3000 Series | Getemed Medizin- UND Informationstechnik AG | 3 |
Showing 12 of 122. All products under Recorder, Magnetic Tape, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110525 | 2011-11-23 |
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.