# K162392: Avazzia

- Pathway: 510(k) (Traditional)
- Applicant: Avazzia, Inc.
- Decided: May 12, 2017 after 259 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: 5 generations back to K940301 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013) Summary page 4.

## Indications for use
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K162392
Methodology: https://510kreport.com/methodology