# K211263: Intrelief

- Pathway: 510(k) (Traditional)
- Applicant: Easymed Instruments Co., Ltd.
- Decided: Dec 30, 2021 after 248 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
Intrelief provides transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) device for the respective indications listed below. TENS: 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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. The Intended Population is Adults and Transitional Adolescent B (18 to <22 years, treated as adult)

Source page: https://510kreport.com/device/K211263
Methodology: https://510kreport.com/methodology