# K240168: N7-S

- Pathway: 510(k) (Traditional)
- Applicant: Nuga Medical Co., Ltd.
- Decided: Sep 12, 2024 after 234 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: 7 generations back to K993461 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220572: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702, Ceragem Co., Ltd. (2022) Summary page 6.
- K153054: N5-1, Nuga Medical Co., Ltd. (2016) Summary page 6.

## Indications for use
The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heatand 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. The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K240168
Methodology: https://510kreport.com/methodology