As of September, the FLEXpine Brace is certified by the Food and Drug Administration (FDA). The product achieved an FDA class one certification, which classifies relatively low-risk devices, such as bandages, electric toothbrushes, and other common items.
The FDA is credible and recognized worldwide for making the most rigorous and prudent marketing approval decisions. The FDA acquisition of the FLEXpine brace demonstrates the product safety and effectiveness.
The FLEXpine Orthosis Lab conducted clinical trials with the Bundang Branch of Seoul National University Hospital’s Orthopedic Department to test how the FLEXpine brace affects scoliosis patients. The results showed that when patients wore the FLEXpine brace for six months, the average Cobb’s angle was decreased by more than 14 degrees.
About 75% of patients were satisfied with the FLEXpine brace after wearing it for six months. Particularly, idiopathic scoliosis patients reported higher satisfaction, as the brace helped maintain their posture. The FLEXpine brace allows for active movement when worn, so it is welcomed by patients who feel uncomfortable in a rigid brace.
Checking the type of scoliosis and body measurements of the patient provides the right size of the product for the patient. The FLEXpine brace is processed after measuring the size of the patient’s upper chest, waist, and pelvis.
Patients can purchase FLEXpine by submitting an X-ray image and body measurement through the company’s website (www.flexpine.com), via email (email@example.com). For ordering on phone or for more information, contact +1 302-313-1259 [15:00-19:00 p.m. PST (U.S. and Canada)] or +82 31-608-2730 [9:00a.m.-18:00p.m. S.Korea local time] on weekdays.
The FLEXpine Orthosis Lab can be reached in 16192 Coastal Highway, Lewes, Delaware and also in S.Korea – 172 Dolma-ro, Bundang-gu, Seongnam, South Korea.