Hello again,

Does anyone on this list have any experience/suggestions on
the FDA's take on incorporation of rechargeable batteries
in patient connected medical devices (like TENS units)?
The regulations have been changing rather dramatically and
the info I had is now out of date and I haven't yet found
anything on-line that seems relevant.

Is it acceptable for the device to connect to a wall wart if
a DPDT switch ensures that it is not possible for a patients
electrodes to have a path to the AC outlet? What is the newest
breakdown voltage spec?

Of course I will research it further, but I'd like some indication
of whether I'd just be wasting my time. (talk about phone book
thick regulatory docs...)

Pointers to TFM appreciated.

And yes, it uses a PIC.

TIA

Robert.Rolf@UAlberta.ca