# DEN210055: The N-SWEAT Patch

- Pathway: De Novo (Direct)
- Applicant: Candesant Biomedical, Inc.
- Decided: Apr 7, 2023 after 490 days
- Product code: QVX (Skin Patch For Treatment Of Hyperhidrosis)
- Device class: 2
- Regulation: 21 CFR 878.4425
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The N-SWEAT Patch is indicated for treatment of primary axillary hyperhidrosis in adults.

Source page: https://510kreport.com/device/DEN210055
Methodology: https://510kreport.com/methodology