21 CFR 890.5660
Therapeutic massager
21 CFR 890.5660 is the regulation titled “Therapeutic massager” in 21 CFR Part 890, Physical Medicine Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite 21 CFR 890.5660 most often, as written in the letters.
- 1 letterour inspection revealed that the Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an…
The regulation
Read the text of 21 CFR 890.5660 (eCFR, as of Sep 1, 2026)
(a) Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.5660.
Latest letters citing it
The letter citing 21 CFR 890.5660 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.