21 CFR 890.5850
Powered muscle stimulator
21 CFR 890.5850 is the regulation titled “Powered muscle stimulator” 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
- 0 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
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 890.5850 (eCFR, as of Sep 1, 2026)
(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
(b) Classification. Class II (performance standards).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.5850.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.90Nonconforming product1 letter cites both
- 21 CFR 882.1275Electroconductive media1 letter cites both
- 21 CFR 882.1320Cutaneous electrode1 letter cites both
- 21 CFR 882.5890Transcutaneous electrical nerve stimulator for pain relief1 letter cites both
Latest letters citing it
The letter citing 21 CFR 890.5850 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.