# K233784: ENSO (Model 2)

- Pathway: 510(k) (Traditional)
- Applicant: Hinge Health, Inc.
- Decided: Feb 23, 2024 after 88 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: 8 generations back to K881114 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160052: CUR Model 1, Thimble Bioelectronics, Inc. (2016) Summary page 5.

## Indications for use
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles. The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.

Source page: https://510kreport.com/device/K233784
Methodology: https://510kreport.com/methodology