Wesper Lab
Wesper Inc. · Model WSWW-RE-K-N-V02-BLO · UDI-DI 00860007837029
Description
Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter. This Device Identification is for a kit that is shipped without a charger.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-29 | NATUS MEDICAL INCORPORATED | The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and m |
| 2021-09-07 | NOX MEDICAL | Error in the device firmware results in the inaccurate detection of device position. |
| 2013-04-24 | Embla System Llc | Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to ove |
| 2011-11-11 | Del Mar Reynolds Medical, Ltd. | When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the |
| 2009-12-03 | Ventus Medical, Inc. | The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kit |
| 2008-05-08 | SagaTech Electronics, Inc. | The outer jacket is receding away from the black sensor prematurely. |
| 2007-10-15 | Respironics, Inc. | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| 2007-10-15 | Respironics, Inc. | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
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