# K022405: Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device; Promax-Libra, Tens Device; Promax-Mic

- Pathway: 510(k) (Special)
- Applicant: Rehabilicare, Inc.
- Decided: Aug 12, 2002 after 27 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 K872657 (1987). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device, Rehabilicare, Inc. (1998) Summary page 2.
- K930865: Staodyn Maxima Iii, Staodyne, Inc. (1993) Summary page 1.
- K872657: Ultrapac II SX Plus (TM), Medical Devices, Inc. (1987) Summary page 1.
- K935132: Home Microcurrent HMC, Medical Devices, Inc. (1994) Summary page 1.

## Most influential descendants
- K081835: Acticare IC and Tse (2009), 3 descendants of its own
- K161091: STIMPOD NMS460 Nerve Stimulator (2017), 2 descendants of its own
- K252712: STIMPOD NMS460 Nerve Stimulator (2026), 0 descendants of its own
- K213802: StimOnTM Pain Relief System (GM2439) (2022), 0 descendants of its own
- K061828: Lorenz Biotech Aptiva, Version 2.13 (2007), 0 descendants of its own

## Indications for use
The model 4400 series of TENS and Microcurrent devices are indicated for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Source page: https://510kreport.com/device/K022405
Methodology: https://510kreport.com/methodology