# K071431: Globus Genesy 1100 Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Domino S.R.L.
- Decided: Sep 21, 2007 after 121 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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: 1 generation back to K031077 (2003). 1 ancestor in all.
29 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 1.

## Most influential descendants
- K090632: Compex Rehab (2009), 28 descendants of its own
- K124016: Empi Phoenix (2013), 25 descendants of its own
- K153704: Strive (2016), 24 descendants of its own
- K170903: Compex Wireless USA (2017), 10 descendants of its own
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own

## Indications for use
The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms: Management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain

Source page: https://510kreport.com/device/K071431
Methodology: https://510kreport.com/methodology