FDA WARNING_LETTER - Medicepts, Inc. - July 23, 2010

On January 25, 2011, the FDA issued a Warning Letter to Medicepts, Inc. following an inspection from July 21-23, 2010, which found the firm manufactures the Spine Six Biomotion Spinal System. The device was deemed adulterated under section 501(t)(1)(B) of the Act because Medicepts lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. It was also misbranded under section 502(o) for failure to submit a 510(k) premarket notification.

The FDA stated that the Spine Six Biomotion Spinal System's claims for cervical/lumbar pain, herniated discs, etc., exceed the limitations for Powered Exercise Equipment (21 CFR 890.5380) and that its combination of motions and fundamentally different scientific technology also exceed the limitations of 21 CFR 890.9(a) and (b).

Additionally, the inspection revealed several Current Good Manufacturing Practice (CGMP) violations of the Quality System (QS) regulation (21 CFR Part 820), including: 1. Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g)), specifically lacking "white box" testing documentation for embedded software. 2. Failure to establish and maintain adequate