# K991397: Transcutaneous Electrical Nerve Stimulator SE-30 Tens

- Pathway: 510(k) (Traditional)
- Applicant: Sein Electronics Co., Ltd.
- Decided: Feb 11, 2000 after 296 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. The FDA summary names its predicate without a number.
- (no number) Graham-Field, Inc. Micro TENS Plus: named in the summary without a submission number

## Indications for use
the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K991397
Methodology: https://510kreport.com/methodology