FDA WARNING_LETTER - Pinook-USA - February 24, 2012

On June 14, 2012, the FDA issued a Warning Letter to Pinook-USA following a February 23-24, 2012 inspection. The firm manufactures therapeutic massagers, including the Mini, iPRO, Beetle, Nano, Mirco, Medi Pro, and MP5. The FDA determined these products are actually powered muscle stimulators and electronic acupuncture devices, not massagers.

The devices are adulterated under Section 501(f)(1)(B) of the Act because Pinook-USA lacks an approved premarket approval (PMA) or investigational device exemption. They are also misbranded under Section 502(o) for failure to submit a 510(k) premarket notification, and under Section 502(t)(2) for failing to furnish required information under Section 519 and 21 CFR Part 803 (Medical Device Reporting).

Specific violations include failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17), and failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). The firm's March 8, 2012 response to the FDA 483 was deemed inadequate as it did not fully address MDR procedure development, implementation, or