# K092990: Amd 6605 Tens/Nmes

- Pathway: 510(k) (Traditional)
- Applicant: Advantageous Medical Devices, LLC
- Decided: Oct 23, 2009 after 25 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 K032954 (2004). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032954: Elpha, Models II 500, II 1000, II 2000, II 3000 and E80, Danmeter A/S (2004) Summary page 2.

## Most influential descendants
- K151922: StimSox (TM) System (2016), 1 descendant of its own
- K171071: StimSox (TM) System (2017), 0 descendants of its own

## Indications for use
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K092990
Methodology: https://510kreport.com/methodology