wesper.coWesper Lab
Wesper, Inc.
WESPER INC. LIC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024722701 | 3024722701 | WESPER INC. LIC | 1 | N | 2026-01-01 | 44-02 11th St. Ste 610 Long Island City NY US 11101 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860007837012 | Wesper Lab - 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 rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and 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 patch2. Thoracic patch3. Pulse oximeterData 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. | 9175400177 | support@wesper.co |
| 00860007837029 | Wesper Lab - 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 patch2. Thoracic patch3. Pulse oximeterData 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. | 9175400177 | support@wesper.co |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 309026 | 1893009163 | K221816 | Wesper Lab | MNR | 2023-03-09 |
| 309026 | 1508898684 | K203343 | Wesper Lab | MNR | 2021-12-21 |
| 309026 | 1889187742 | K191088 | Checkme O2 Pulse Oximeter | DQA | 2019-12-02 |
Product Codes Associated With Registrations#
PMN#
GUDID#
CASSIE - Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices.Cassie is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders in adults.The Cassie output may be displayed and edited by a qualified healthcare professional. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
2025-05-09
Wesper Lab - 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 patch2. Thoracic patch3. Pulse oximeterData 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.
2024-07-30
Wesper Lab - 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 rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and 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 patch2. Thoracic patch3. Pulse oximeterData 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.
2023-08-31