# K212285: Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

- Pathway: 510(k) (Traditional)
- Applicant: Oriental Inspiration Limited
- Decided: Dec 22, 2021 after 154 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TENS: 1)The device is designed to be used 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. 2) It is also intended to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: 1) The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K212285
Methodology: https://510kreport.com/methodology