# K041172: Basba E-Machine

- Pathway: 510(k) (Traditional)
- Applicant: Basba, Inc.
- Decided: Nov 18, 2004 after 198 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
Longest line of descent: 1 generation back to K021755 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021755: Apex Medical Digital Tens TS1211, TS1212, Apex Medical Corp. (2002) Summary page 1.
- K033455: Electro-Nerve Stimulator Tens, Model BMLS03-5, Biomedical Life Systems, Inc. (2004) Summary page 1.

## Indications for use
The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K041172
Methodology: https://510kreport.com/methodology