21 CFR 890.5290 - Shortwave diathermy.

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There are 2 Updates appearing in the Federal Register for 21 CFR 890. View below or at eCFR (GPOAccess)
§ 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-03; vol. 79 # 128 - Thursday, July 3, 2014
    1. 79 FR 37948 - Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 4, 2014. The classification was applicable on December 18, 2013.
      21 CFR Part 890

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 890 after this date.

  • 2014-09-22; vol. 79 # 183 - Monday, September 22, 2014
    1. 79 FR 56532 - Reclassification of Iontophoresis Devices Intended for Any Other Purposes
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments by December 22, 2014. See section XII for the proposed effective date of a final order based on this proposed order.
      21 CFR Part 890