21 CFR 890.5170 - Powered flotation therapy bed.

Status message

There are 2 Updates appearing in the Federal Register for 21 CFR 890. View below or at eCFR (GPOAccess)
§ 890.5170 Powered flotation therapy bed.
(a) Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

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
      GPO FDSys XML | Text
      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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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
      GPO FDSys XML | Text
      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