21 CFR 882.5890
Transcutaneous electrical nerve stimulator for pain relief
21 CFR 882.5890 is the regulation titled “Transcutaneous electrical nerve stimulator for pain relief” in 21 CFR Part 882, Neurological Devices. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 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 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 882.5890 (eCFR, as of Sep 1, 2026)
(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
(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 882.5890.
- 21 CFR 807.81When a premarket notification submission is required2 letters cite both
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.30Design controls2 letters cite both
- 21 CFR 882.1275Electroconductive media2 letters cite both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.90Nonconforming product1 letter cites both
- 21 CFR 882.1320Cutaneous electrode1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 882.5890 that FDA posted most recently.
- DevicesView ZIIP, Inc.ZIIP Halo 2.0, ZIIP DOT, ZIIP Gels (Golden gel, Clear gel, Silver gel, Crystal gel, Electric complex gel)IssuedMay 22, 2026PostedJul 14, 2026
- DevicesView Neurotris, Inc. dba A1 EngineeringPowered Muscle Stimulator devices (SX2500, SX3800, SX4500, SVX650, PICO Toner) and accessories (electrodes, gels, spray)IssuedOct 27, 2023PostedNov 7, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.