# K062616: Wellnesspro 2010

- Pathway: 510(k) (Traditional)
- Applicant: Intelsource Group, Inc.
- Decided: Jul 6, 2007 after 304 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 3 generations back to K971437 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060669: Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300, Healthonics, Inc. (2006). Cleared while this submission was under review Summary page 1.
- K041575: Fenzian Treatment System, Eumedic Limited (2004) Summary page 1.

## Indications for use
The Wellness Pro 2010 is an Electrotherapy Unit that is used for the following: 1. Relief of chronic, intractable pain. 2. Adjunctive treatment of post surgical or post-traumatic acute pain

Source page: https://510kreport.com/device/K062616
Methodology: https://510kreport.com/methodology