# K032928: Mediphysics Pain Treatment System, Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Mediphysics Pain Centers of America
- Decided: Dec 19, 2003 after 88 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). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894127: Lumiscope Model 1000/Apcc Model 1000, Lumiscope Co., Inc. (1989) Summary page 1.
- K970203: Epix VT, Empi (1997) Summary page 1.
- K883911: Electro-Acuscope 85, Biomedical Design Instruments (1990) Summary page 1.
- K895473: DSX (TM), Digital SX, Quantum DSX, Model 4700S, Medical Devices, Inc. (1989) Summary page 1.
- K020020: The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact Tens (WL-2302), Well-Life Healthcare, Inc. (2002) Summary page 1.
- K020803: Cefar Medical AB Cefar Primo, Cefar Medical AB (2002) Summary page 1.

## Most influential descendants
- K070474: Newlife Sciences LLC, Model TMR (2007), 1 descendant of its own
- K202186: TrueRelief Device (2021), 0 descendants of its own

## Indications for use
The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K032928
Methodology: https://510kreport.com/methodology