# K033253: S21 Transcutaneous Electrical Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Micro Current Technology, Inc.
- Decided: Oct 21, 2003 after 13 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The S21 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The S21 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

Source page: https://510kreport.com/device/K033253
Methodology: https://510kreport.com/methodology