# K032003: Premier Plus

- Pathway: 510(k) (Traditional)
- Applicant: American Imex
- Decided: Jan 7, 2004 after 194 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
No predicates in its family tree.
16 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061516: Staodyn Max Preset, Model 4470 (2007), 15 descendants of its own
- 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

## Indications for use
Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Source page: https://510kreport.com/device/K032003
Methodology: https://510kreport.com/methodology