# Hi-Dow International, Inc.

- Location (FDA's records): Maryland Heights, MO
- FDA decisions: 6 (2011–2024): 6 510(k) clearances
- Product codes: NUH (3), GXY (2), ILX (1)
- 510(k) review time since 2016: median 179 days, against 134 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 13 (1 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
- Endurance Therapeutics: 1 (https://510kreport.com/company/endurance-therapeutics)
- Prizm Medical, Inc.: 1 (https://510kreport.com/company/prizm-medical)
- Compex S.A.: 1 (https://510kreport.com/company/compex)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)

## Firms that cite its devices most
- Gymmax Technology Shenzhen Co., Ltd.: 2 (https://510kreport.com/company/gymmax-technology-shenzhen)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)
- Prospera Corporation: 1 (https://510kreport.com/company/prospera)
- Medirune Co, Ltd.: 1 (https://510kreport.com/company/medirune)
- Pinook USA: 1 (https://510kreport.com/company/pinook-usa)
- Hong Qiangxing (Shenzhen) Electronics Limited: 1 (https://510kreport.com/company/hong-qiangxing-shenzhen-electronics)
- Sunmas (H.K.) Trading Limited: 1 (https://510kreport.com/company/sunmas-hk-trading)
- Caerus Corporation: 1 (https://510kreport.com/company/caerus)

## Its most-cited devices
- K102598: HI-Dow-XP (2011), cited by 9
- K210383: Wrap Accessory Electrodes (2021), cited by 1
- K202337: Pulsed electromagnetic field wrap (2020), cited by 1
- K190617: Wrap accessory electrodes (2019), cited by 1
- K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N) (2017), cited by 1

## Recent decisions
- K233461: Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (Jan 19, 2024)
- K210383: Wrap Accessory Electrodes (Nov 12, 2021)
- K202337: Pulsed electromagnetic field wrap (Dec 15, 2020)
- K190617: Wrap accessory electrodes (Jul 2, 2019)
- K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N) (Aug 4, 2017)
- K102598: HI-Dow-XP (May 13, 2011)

Source page: https://510kreport.com/company/hi-dow-international