# K172971: BMLS16-1

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Life Systems, Inc.
- Decided: Jul 8, 2018 after 285 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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 BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.

Source page: https://510kreport.com/device/K172971
Methodology: https://510kreport.com/methodology