Over the counter

• Arm-type Fully Automatic Digital Blood Pressure Monitor Model BM 92

  Device Information: The Digital Blood Pressure Monitor Model BM 92 is non-invasive and uses an oscillometric method to measure blood pressure and pulse rate. It features an arm cuff and an electric pump for inflation, with a…

  September 20, 2024

  Cardiology, Cardiovascular Surgery, Family medicine, General Practice

  Blood pressure monitor, Home use medical device, Over the counter, Pulse rate monitor

• EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

  Device Information The EGENS Pregnancy Test Midstream devices are qualitative immunochromatographic assays designed for early pregnancy detection. They consist of a nitrocellulose test strip housed in plastic, usable in either dip or midstream mode. Both tests detect…

  September 13, 2024

  Clinical Chemistry, Obstetrics

  hCG, Immunoassay, Lateral Flow Assay, Over the counter, Pregnancy Detection Test, Urine Test

• Epilaser Pro

  Device Information The Epilaser Pro uses laser energy at 808 or 980nm wavelengths to target and disable hair follicles. It features a skin tone sensor to ensure appropriate skin compatibility before activation and includes an automatic hair-targeting…

  September 12, 2024

  Dermatology, General Surgery, Plastic Surgery

  Hair removal, Laser Devices, Medical Algorithms, Over the counter, Permanent hair reduction, Skin tone sensor

• MightySat – OTC

  Device Information Indications The Masimo MightySat-OTC is intended for spot-checking functional oxygen saturation (SpO2) of arterial hemoglobin and pulse rate (PR).  Intended Use (Including Who Can Use This Device) The device is intended for use by individuals…

  September 7, 2024

  Anesthesiology, Respiratory Medicine

  Over the counter, Pulse Oximeter, SpO2 Monitoring