A handheld TENS (transcutaneous electrical nerve stimulation) therapeutic equipment indicated to perform acute pain relief on human, the manufacturer must be currently an U. S. FDA registered foreign medical equipment manufacturer (preferrable in China); Be ISO13485: 2016 /USFDA 21CFR820 certified; Be ISO14971: 2019 qualified able to demonstrate the manufacturer's Post Market Surveillance (PMS) capability for monitoring the safety of the device once released on the market, otherwise MDSAP audit is necessary; Be able to complete the 510K approval process required by U. S. FDA for Class 2 medical equipment; And be able to generate Unique Device Identifier (UDI) to upload to the Global Unique Device Identification Database (GUDID) of U. S. FDA ready for the device that manufactured within the manufacturer's facility exporting to the United States of America.