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ReActiv8 has FDA Pre-Market Approval (PMA) in the US (2020), CE Mark in Europe (2016), TGA approval in Australia (2019), and is commercially available in US, Australia, Germany, UK, and other European markets. Clinical trials including ReActiv8-B (pivotal IDE, positive 3-5 year data), ReActiv8-C (post-market), and RESTORE (randomized superiority over standard care) demonstrate long-term efficacy in reducing pain and improving function in mechanical chronic low back pain associated with multifidus dysfunction.[1][2][3][8][14]
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