# K102051: Pain Buddy

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Life Systems, Inc.
- Decided: Jul 29, 2011 after 373 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K152374: LL Tens 160A, LL Tens 160B (2016), 3 descendants of its own
- 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
- K160255: HBOTC Muscle and Nerve Stimulator (2016), 0 descendants of its own

## Indications for use
T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K102051
Methodology: https://510kreport.com/methodology