# K061516: Staodyn Max Preset, Model 4470

- Pathway: 510(k) (Traditional)
- Applicant: Compex Technologies, Inc.
- Decided: Feb 6, 2007 after 250 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: 1 generation back to K032003 (2004). 1 ancestor in all.
15 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032003: Premier Plus, American Imex (2004) Summary page 2.

## Most influential descendants
- K110350: Kneehab XP (2011), 9 descendants of its own
- K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator (2015), 7 descendants of its own
- K163067: CyMedica e-vive™ System; CY-1000 (2016), 4 descendants of its own
- K120398: Witouch Pro (2012), 3 descendants of its own
- K212832: TimeWaver Frequency (2021), 1 descendant of its own

## Indications for use
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K061516
Methodology: https://510kreport.com/methodology