Bioelectronics Corp (BIEL)

[kidnova]

Or it could simply be that BIEL doesn't understand what the classification actually means. BIEL describes it as a "non-thermal" category in their FDA update when in fact the official description of the ILX category is "diathermy, shortwave, for use other than applying therapeutic deep heat". Nowhere in the official description does it mention non-thermal, simply that the purpose of the device is for something other than deep heat of the tissue. The FDA has never claimed that the devices don't produce heat, just that wasn't the purpose of the devices, so we're back again to the mechanism of action for BIEL's products.

Given how BIEL has historically marketed and described the device the ILX category is absolutely the right place to put it, IMO. They've changed their tune, of course, but they weren't putting up much of a fight when they got their initial 510k approval as an ILX device.

Sec. 890.5290 Shortwave diathermy.
(a)Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions --(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

(2)Classification. Class II (performance standards).

(b)Shortwave diathermy for all other uses --(1)Identification. A shortwave diathermy for all other uses except for the treatment of malignancies is a device that applies to the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.

(2)Classification. Class III (premarket approval).

(c)Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See 890.3.