Bioelectronics Corp (BIEL)

[srinsocal]

Better take another look at the 510K

BIEL's 510K, K152432, Cleared ActiPatch as a,
Nonthermal Shortwave Therapy Device indicated for over the counter use for the treatment of pain, under Product Code PQY.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152432

Laboratory test have shown that ActiPatch has a Biologic effect up to 4-5 centimeters (1.57 - 1.96 inches) deep.

Non-thermal PSWT (ActiPatch): Clinical effects such as chronic pain relief and improved wound recovery were observed even when PSWT power levels were reduced to a point where tissue heating could not be observed. These effects were termed “non-thermal effects” and the use of non-thermal, pulsed, low power RF fields came to be known as non-thermal PSWT. The ActiPatch falls under the category of non-thermal PSWT and has made use of advances in microelectronics to achieve its innovative, wearable size. Recent clinical evidence attributes the mechanism of action through Stochastic Resonance. The wearable, long-lasting nature of the ActiPatch means that it is the only evidencebacked electroceutical device on the market capable of providing continuous pain relief. Unlike TENS, it can be worn over clothing/bandaging, for extended periods of time without lingering paresthesia. There is evidence that the ActiPatch raises pain tolerance thresholds, so it is hypothesized that over time, the ActiPatch provides pain relief by habituating nerves in the painful area to its sub-sensory stimuli.

When the antenna is placed over an area to be treated, RF energy from the antenna is transferred into the target tissue as a localized therapy, and has an effective penetration depth of up to 6 cm.The therapeutic area is confined to the area within the 12cm diameter loop.

http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-Mechanism-of-Action-and-Clinical-Evidence-Packet.pdf (page 4)