# K130723: FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain Relief Plaster,FDES107 Abdominal

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Co., Ltd.
- Decided: Feb 7, 2014 after 326 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940301 (1994). 7 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 2.
- K030708: Slendertone Flex Abdominal Training System, Type 515, Bio-Medical Research, Ltd. (2003) Summary page 2.

## Most influential descendants
- K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N) (2017), 1 descendant of its own
- K241785: StarFormer (M008-3T) (2025), 0 descendants of its own

## Indications for use
FDES 106 (ED406) Mini TENS &EMS Device For program NI, B and H of TENS mode To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. For program El and E2 of EMS mode Used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDES1O6A (ED4O6AJ Multi-function Mini TENS &EMS Device For pro gram NI1, B and H of TENS mode To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities. For pro gram El and E2 of EMS mode Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance. FDES1O5 (ED405) Pain Relief Plaster To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. FDES 107 (ED407) Abdominal Fitness Belt Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.

Source page: https://510kreport.com/device/K130723
Methodology: https://510kreport.com/methodology