# Everyway Medical Instruments Co.,Ltd

- Location (FDA's records): Roswell, GA
- FDA decisions: 29 (2001–2025): 29 510(k) clearances
- Product codes: NUH (14), GXY (4), IPF (3), GZJ (3), KPI (2), NFO (1), LIH (1), ITH (1)
- 510(k) review time since 2016: median 90 days, against 135 for FDA's reviews in the same codes and years (9 of 13 faster)
- Predicates its devices cite: 20 (6 its own); citations of its devices by later devices: 23 (6 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
- Well-Life Healthcare Limited: 3 (https://510kreport.com/company/well-life-healthcare)
- Gemore Technology Co, Ltd.: 2 (https://510kreport.com/company/gemore-technology)
- Transamerica Medical Systems: 2 (https://510kreport.com/company/transamerica-medical-systems)
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Carol Cole Company: 1 (https://510kreport.com/company/carol-cole)
- Prizm Medical, Inc.: 1 (https://510kreport.com/company/prizm-medical)
- Theratech, Inc.: 1 (https://510kreport.com/company/theratech)
- Neurotron Medical: 1 (https://510kreport.com/company/neurotron-medical)

## Firms that cite its devices most
- Koalaty Products, Inc.: 3 (https://510kreport.com/company/koalaty-products)
- Axelgaard Mfg. Co., Ltd.: 2 (https://510kreport.com/company/axelgaard-mfg)
- Li-Tek Electronic Technology Corporation: 2 (https://510kreport.com/company/li-tek-electronic-technology)
- Wuxi Jiajian Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/wuxi-jiajian-medical-instrument)
- Well-Life Healthcare Limited: 1 (https://510kreport.com/company/well-life-healthcare)
- Everyway Medical Instruments Co., Ldt.: 1 (https://510kreport.com/company/everyway-medical-instruments-co-ldt)
- Medihightec Medical Co., Ltd.: 1 (https://510kreport.com/company/medihightec-medical)
- Naimco, Inc.: 1 (https://510kreport.com/company/naimco)

## Its most-cited devices
- K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems (2002), cited by 4
- K083302: Lifecare Electrodes (2009), cited by 3
- K071951: Comfy Series: EV-804, EV-805 & EV-806 (2007), cited by 3
- K142794: Everyway Facial MENS (2015), cited by 2
- K012463: Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM Round, Lifecare 4*6 CM Oval (2002), cited by 2
- K020749: Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens (2002), cited by 2

## Recent decisions
- K251856: Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (Nov 21, 2025)
- K222488: Everyway Analog OTC TENS (Nov 15, 2022)
- K213116: Everyway Incontinence Stimulation System (Dec 3, 2021)
- K202849: Everyway Analog OTC TENS, model N103A/N302 (Dec 22, 2020)
- K202470: Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (Nov 25, 2020)
- K202317: Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (Nov 13, 2020)
- K201335: Li-Battery powered OTC TENS/EMS Combination Stimulator (Oct 24, 2020)
- K192589: Everyway OTC TENS/EMS Combination (Dec 19, 2019)

Source page: https://510kreport.com/company/everyway-medical-instruments