21 - 807.65 Subpart D - Exemptions, Paragraphs (d) & (f) Excludes and exempts from regulation:

(d) Licensed practitioners, including physicians, dentist, and optometrist, who manufacture or otherwise alter devices for use in their practice.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching or analysis, and do not introduce such devices into commercial distribution.

Unless you have a Health/Medical Freedom Act, that has been passed in your particular State, then you as a Healing Practitioner should also be AWARE of the following Legal Steps, when using UNAPPROVED Medical Device(s) with your Client/Patient.
1. The Client/Patient must be told that the UNAPPROVED Medical Device(s) is "FOR EXPERIMENTAL USE ONLY".
NOTE: The UNAPPROVED Medical Device(s) must also be labeled "FOR EXPERIMENTAL USE ONLY".

2. The Client/Patient can ONLY be told that the UNAPPROVED Medical Device(s) can balance, detox, energize, oxygenate, polarize and/or stimulate the Body, but NOT told that it will HEAL or CURE the Body and particularly of a Disease, such as Cancer or AIDS!

3. The Client/Patient must operate the UNAPPROVED Medical Device(s) his/herself.

4. The Client/Patient must NOT be charged a Fee for using the UNAPPROVED Medical Device(s).
NOTE: The Client/Patient can be told that you do accept Donations with a MINIMUM Donation stated, unless the Amount is UNREASONABLE!

Revised 8/22/03