# K143059: TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

- Pathway: 510(k) (Traditional)
- Applicant: Tone-A-Matic International, Inc.
- Decided: Jan 26, 2015 after 94 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 {Transcutaneous Electric Nerve Stimulation): 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. EMS (Electric Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K143059
Methodology: https://510kreport.com/methodology