# Bioness, Inc.

- Location (FDA's records): Valencia, CA
- FDA decisions: 13 (2011–2022): 13 510(k) clearances
- Product codes: GZI (9), GZF (4)
- Predicates its devices cite: 16 (10 its own); citations of its devices by later devices: 20 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ness-Neuromuscular Electrical Stimulation Systems: 3 (https://510kreport.com/company/ness-neuromuscular-electrical-stimulation-systems)
- Innovative Neurotronics, Inc.: 2 (https://510kreport.com/company/innovative-neurotronics)
- Bio-Medical Research, Ltd.: 1 (https://510kreport.com/company/bio-medical-research)

## Firms that cite its devices most
- Bioventus, LLC: 2 (https://510kreport.com/company/bioventus)
- Innovative Neurotronics, Inc.: 1 (https://510kreport.com/company/innovative-neurotronics)
- Myndtec, Inc.: 1 (https://510kreport.com/company/myndtec)
- Neuvotion, Inc.: 1 (https://510kreport.com/company/neuvotion)
- Synapse Biomedical, Inc.: 1 (https://510kreport.com/company/synapse-biomedical)
- Evolution Devices, Inc.: 1 (https://510kreport.com/company/evolution-devices)
- Cionic: 1 (https://510kreport.com/company/cionic)
- Guangzhou Longest Science & Technology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-longest-science-technology)

## Its most-cited devices
- K190285: L300 Go System (2019), cited by 3
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) (2011), cited by 3
- K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device (2013), cited by 3
- K162407: L300 Go System (2017), cited by 2
- K173682: L300 Go System (2018), cited by 2
- K211965: StimRouter Neuromodulation System (2022), cited by 2

## Recent decisions
- K211965: StimRouter Neuromodulation System (Feb 23, 2022)
- K200482: StimRouter Neuromodulation System (Mar 27, 2020)
- K200262: L100 Go System (Mar 4, 2020)
- K190047: StimRouter Neuromodulation System (Oct 31, 2019)
- K191587: L360 Thigh System (Sep 12, 2019)
- K190285: L300 Go System (Mar 14, 2019)
- K173682: L300 Go System (Mar 9, 2018)
- K162407: L300 Go System (Jan 27, 2017)

Source page: https://510kreport.com/company/bioness