Bioelectronics Corp (BIEL)

[GetSeriousOK]

Let's revisit the 510(k) documentation for RecoveryRx that JNDouble1 found.

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf

In the table on page 2,
"Antenna size" is listed as "12cm or 6 cm diameter."
"Treatment Area" is listed as "110cm2 or 30cm2."
"Peak spatial power density" is the same for both antenna sizes and both treatment areas.

On page 3 it states

The subject RecoveryRx is identical to the primary predicate [Actiband] and differs from the secondary predicate [Ivivi] only in antenna size/pulse rate (Table 2), but does not affect the average spatial power density levels.

The Actipatch documentation is the same:

https://www.accessdata.fda.gov/cdrh_docs/pdf15/k152432.pdf

Key take-aways:
1. Changing the antenna length or treatment area does not change the peak power density (p. 2) or the average power density (p. 3)
2. BIEL already has FDA clearance for different antenna lengths and treatment areas.

Staelin specifically stated that the company expects to submit an "expedited" 510(k) for the new higher-power device. If it needs a new 510(k) it HAS to be something other than a change in antenna length or treatment area.