# K152374: LL Tens 160A, LL Tens 160B

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics, Ltd.
- Decided: Jan 13, 2016 after 145 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
Longest line of descent: 1 generation back to K102051 (2011). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102051: Pain Buddy, Biomedical Life Systems, Inc. (2011) Summary page 5.

## Most influential descendants
- K210223: Transcutaneous Electrical Nerve Stimulator (2021), 2 descendants of its own
- K231425: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (2024), 1 descendant of its own
- K252688: Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (2025), 0 descendants of its own

## Indications for use
The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic 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/K152374
Methodology: https://510kreport.com/methodology