# K141921: Hivox Spopad Ems

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Jan 16, 2015 after 184 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: 6 generations back to K010335 (2001). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092476: Sport-Elec Body Control System, Model 4M, Sport-Elec (2010) Summary page 6.

## Most influential descendants
- K192264: HIVOX Spopad EMS SP-911, SP-921 (2019), 1 descendant of its own
- K241119: Transcutaneous Electrical Nerve Stimulator (K6106) (2024), 0 descendants of its own

## Indications for use
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Source page: https://510kreport.com/device/K141921
Methodology: https://510kreport.com/methodology