Description of Event or Problem · 0
ON (B)(6) 2024, I UNDERWENT A DEEP TISSUE MASSAGE WITH CUPPING, USING A DEVICE MANUFACTURED BY DONGBANG MEDICAL CO. LTD., KOREA, SOUTH (ESTABLISHMENT REGISTRATION OR FEI NUMBER: (B)(4), OWNER OPERATOR NUMBER: (B)(4). THE SPECIFIC DEVICE USED WAS A ¿PRESSURE APPLYING - PLASTIC CUPPING SET; SPRING LOADED PROBE¿ (CODE: 890.5765). DURING THE PROCEDURE, BRUISING DEVELOPED ALMOST IMMEDIATELY AFTER THE CUPS WERE APPLIED FOR ABOUT 2-5 MINUTES. I WOULD LIKE TO INQUIRE ABOUT THE FOLLOWING: IS BRUISING FROM CUPPING CLASSIFIED AS A DEEP TISSUE INJURY, AND COULD IT BE CONSIDERED AN ADVERSE MEDICAL EFFECT? WHO REGULATES THE USE OF THIS LEVEL 1 DEVICE? IS THE USE OF THIS DEVICE RESTRICTED TO LICENSED PROFESSIONALS WITH MANUAL THERAPY IN THEIR SCOPE OF PRACTICE, SUCH AS PHYSICAL THERAPISTS OR MASSAGE THERAPISTS, OR CAN IT BE USED BY ANYONE? THANK YOU FOR YOUR ATTENTION TO THIS MATTER. I LOOK FORWARD TO YOUR GUIDANCE AND CLARIFICATION. UNSPSC CODE: 53131700. ASIN: (B)(4). SOUTH KOREAN VACUUM CUPPING THERAPY SET WITH PISTOL HANDGUN AND EXTENSION TUBE.