# K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Apr 28, 2006 after 88 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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 K040512 (2004). 1 ancestor in all.
14 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401, Well-Life Healthcare, Inc. (2004) Summary page 1.

## Most influential descendants
- K090042: Painmaster MCT Patch (2009), 11 descendants of its own
- K130114: Painmaster MCT Patch (2013), 5 descendants of its own
- K120500: The Pain Pilot (a.K.a Pain Pilot) (2012), 4 descendants of its own
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (2015), 2 descendants of its own
- K133789: Dolphin Neurostim Otc (2015), 1 descendant of its own

## Indications for use
The model GM31OPP, GM32OPP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K060222
Methodology: https://510kreport.com/methodology