# K153054: N5-1

- Pathway: 510(k) (Traditional)
- Applicant: Nuga Medical Co., Ltd.
- Decided: Feb 5, 2016 after 108 days
- Product code: JFB (Table, Physical Therapy, Multi Function)
- Device class: 2
- Regulation: 21 CFR 890.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041200 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111329: NM-7000, Nuga Medical Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K240168: N7-S (2024), 0 descendants of its own

## Indications for use
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. - Temporary relief of minor joint pain associated with arthritis. - The temporary increase in local circulation where applied. - Relaxation of muscle.

Source page: https://510kreport.com/device/K153054
Methodology: https://510kreport.com/methodology