# K061650: Select Tens, Model 4600S

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jan 22, 2007 after 223 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: 2 generations back to K881114 (1988). 4 ancestors in all.
56 later devices descend from it; 7 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970203: Epix VT, Empi (1997) Summary page 1.
- K982828: Forte, Models CPS 400 Stim, CPS 200 Stim, Chattanooga Group, Inc. (1998) Summary page 1.

## Most influential descendants
- K113037: Pain-Aid (2012), 33 descendants of its own
- K131159: Smartrelief (2013), 32 descendants of its own
- K093324: Empi Continuum (2010), 26 descendants of its own
- K124016: Empi Phoenix (2013), 25 descendants of its own
- K153704: Strive (2016), 24 descendants of its own

## Indications for use
The Empi® SELECT 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 for post-surgical and post-trauma acute pain.

Source page: https://510kreport.com/device/K061650
Methodology: https://510kreport.com/methodology