Description of Event or Problem · 0
I BOUGHT THIS LEG MASSAGER FROM AMAZON IN THE UNITED STATES. AS AN EXPERIENCED MASSAGER USER, I AM SURE THAT ITS MEDICAL CODE IS: IRP, AND IT FALLS WITHIN THE SCOPE OF PRE-MARKET SUPERVISION AND REQUIRES 510(K). HOWEVER, AFTER SEARCHING THE PRODUCT MODEL THROUGH THE FDA MEDICAL DEVICE REGISTRATION DATABASE, I STILL COULD NOT FIND ANY INFORMATION ABOUT THIS PRODUCT. MOREOVER, THEY SELL A LARGE NUMBER OF LEG MASSAGERS WITH DIFFERENT DESIGNS. EACH INDIVIDUALLY DESIGNED MASSAGER MODEL SHOULD BE APPROVED BY 510(K) SEPARATELY. I FOUND THAT THE STRENGTH OF THE AIRBAG MASSAGE MADE ME FEEL PAINFUL, AND IT PRESSED MY LEGS VERY PAINFULLY WHEN USED. I DOUBT THE SAFETY OF THE PRODUCT. I TRIED TO ASK THEM TO PROVIDE ANY EVIDENCE TO PROVE WHETHER THIS PRODUCT HAS BEEN APPROVED BY 510K, BUT THE SELLER COULD NOT PROVIDE ANY INFORMATION. I THINK THIS PRODUCT, INCLUDING THE PRODUCTS SOLD BY THIS STORE, ARE ALL NON-COMPLIANT. THEY SELL PRODUCTS THAT ARE NOT REGISTERED WITH THE US FOOD AND DRUG ADMINISTRATION (510K REGISTRATION) AND DO NOT MEET US REGULATORY REQUIREMENTS. I AM WORRIED THAT CONTINUED USE MAY HAVE ADVERSE EFFECTS ON ME AND MY FAMILY. IN ADDITION, THE BRAND HAS HUGE SALES ON AMAZON, RANKING AMONG THE TOP THREE IN THE SAME CATEGORY ALL YEAR ROUND. THOUSANDS OF UNREGULATED AND SUBSTANDARD PRODUCTS ARE SOLD TO THE AMERICAN PUBLIC EVERY DAY. THEY ARE LIKELY TO AFFECT THE SAFETY OF CONSUMERS AND EVEN CAUSE A LARGE NUMBER OF SAFETY ACCIDENTS. PRODUCTS THAT DO NOT MEET REGULATORY REQUIREMENTS SHOULD NOT APPEAR ON THE MARKET. I HOPE THAT AN INVESTIGATION CAN BE CONDUCTED ON NON-COMPLIANT PRODUCTS, WHICH WILL PROTECT THE SAFETY OF TENS OF THOUSANDS OF AMERICANS. LINKS TO ONE OF PRODUCTS: HTTPS://WWW.AMAZON.COM/FIT-KING-LEG-AIR-CIRCULATION/DP/B07P3JJ2YK/REF=ZG_BS_G_3767541_D_SCCL_4/133-4787293-6943220?PSC=1 THE SELLER'S STORE LINK? HTTPS://WWW.AMAZON.COM/STORES/FITKING/PAGE/23EFD247-3C4B-4E4C-8061-3B2F44CA5B88?REF_=AST_BLN&STORE_REF=BL_AST_DP_BRANDLOGO_STO. MUSCLE PAIN, REDNESS AND SWELLING.