Air Pressure Therapy System: VU-IPC06 510(k) premarket notification-weiuit.com

Air Pressure Therapy System: VU-IPC06 510(k) premarket notification

August 17, 2021

Air Pressure Therapy System: VU-IPC06 510(k) premarket notification

FDA have reviewed our Section 510(k) premarket notification of intent to market the device referenced

Air Pressure Therapy System: VU-IPC06 and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).