# K143207: Revitive IX (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Actegy, Ltd.
- Decided: Mar 23, 2015 after 136 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: 5 generations back to K940301 (1994). 22 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133965: Otc Ems Stimulator, Shenzhen Dongdixin Technology Co., Ltd. (2014) Summary page 4.
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013) Summary page 4.
- K123354: Revitive IX, Actegy, Ltd. (2013) Summary page 4.

## Most influential descendants
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), 11 descendants of its own
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), 5 descendants of its own
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator (2021), 4 descendants of its own
- K240234: BTL-899MS (2024), 2 descendants of its own
- K163611: Pain Therapy Device (2017), 2 descendants of its own

## Indications for use
To temporarily increase local blood circulation in healthy leg muscles. To stimulate healthy muscles in order to improve and facilitate muscle performance. For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

Source page: https://510kreport.com/device/K143207
Methodology: https://510kreport.com/methodology