Like I said, today is the day... My dream and my fortune cookies were both on the 25th. One of them said "Your luck has been completely changed today." I hadn't even seen that page. Volume is already 4mil with a rise in PPS. Today is the day!
Ours is still Class III though. If you click the 890.5290 link though you will see:
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES
Subpart F--Physical Medicine Therapeutic Devices 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.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
