Henley Healthcare, Sugar Land, TX.

Henley Healthcare, Sugar Land, TX, Sept. 20 (Dallas). The letter notified Henley that its Fluidotherapy devices were misbranded due to violations of medical device reporting (MDR) regulations. FDA noted two unreported incidents involving a fire triggered by contact between a foam distributor and a heater, and a short circuit leading to "spark/flame" caused by bolts that contacted electrical leads for a heater. The agency took the firm to task for eight claims made in promotional materials including several the firm had agreed to delete. These included "continuously kills bacteria," "post-surgical therapy" and "causes mechanical and thermal stimulation which produces counter-irritation." The letter continued with citations for failure to: have an adequate device master record for component specifications; establish acceptance activities to include inspections, tests, or other verification activities to assure conformance; and monitor and control process parameters, component and device characteristics during production. FDA called on the firm to submit a description of Fluidotherapy models for which no 510(k) had been submitted. The 13-page warning letter covered 13 other deviations, including those for complaint handling, design control and validation. The inspection took place from Feb. 24 to Mar. 19. C-H, Design, F-B, Val