Vitalograph , Ltd. · Class II · Cleared Dec 3, 2025
| K-number | K253293 |
| Device name | VitaloJAK Clinic (Model 7100) |
| Applicant | Vitalograph , Ltd. |
| Product code | DSH |
| Device class | Class II |
| Decision date | Dec 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2800 |
The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive, battery-operated device that records and stores cough sounds from patients for later analysis on a Windows PC. It is indicated to aid in assessing cough in adults and pediatric patients aged 8 years and older presenting with suspected chronic cough under clinical supervision.
The device uses an acoustic sensor placed on the suprasternal notch to record cough sounds at 8 kHz sampling rate. Key changes from the predicate include: removal of the microphone and LCD display, extension of maximum recording duration from 24 to 72 hours, upgrade from Compact Flash to 32GB internal memory with USB connectivity, redesigned user interface with simplified button layout, and addition of VitaloJAK Studio software for device configuration and data download.
EN 60601-1:2006+A1:2013+A2:2021 (safety), EN 60601-1-11:2015+A1:2021 (home use), EN 60601-1-2:2015+A1:2021 (EMC), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation). Bench testing included post-aging performance, drop testing, transportation testing, durability, human factors validation, and audio sensor testing.
View the full FDA submission: accessdata.fda.gov