# Jkh Health Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 10 (2016–2025): 10 510(k) clearances
- Product codes: NUH (3), IRP (3), JOW (2), FLL (1), IMI (1)
- 510(k) review time since 2016: median 119 days, against 145 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 12 (4 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
- Manamed, Inc.: 2 (https://510kreport.com/company/manamed)
- Zenith Technical Innovations: 2 (https://510kreport.com/company/zenith-technical-innovations)
- Ezfit Technology, Inc.: 1 (https://510kreport.com/company/ezfit-technology)
- Breg, Inc.: 1 (https://510kreport.com/company/breg)
- ZetrOZ Systems, LLC: 1 (https://510kreport.com/company/zetroz-systems)
- Shenzhen Jingkehui Electronic Co.., Ltd.: 1 (https://510kreport.com/company/shenzhen-jingkehui-electronic)
- Nice Recovery Systems, LLC: 1 (https://510kreport.com/company/nice-recovery-systems)

## Firms that cite its devices most
- Jkh USA, LLC: 2 (https://510kreport.com/company/jkh-usa)
- Hivox Biotek, Inc.: 2 (https://510kreport.com/company/hivox-biotek)
- Shenzhen Osto Technology Company Limited: 1 (https://510kreport.com/company/shenzhen-osto-technology)
- Gymmax Technology Shenzen Co., Ltd.: 1 (https://510kreport.com/company/gymmax-technology-shenzen)
- Shenzhen Xft Medical Limited: 1 (https://510kreport.com/company/shenzhen-xft-medical)
- Umeheal, Ltd.: 1 (https://510kreport.com/company/umeheal)

## Its most-cited devices
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (2017), cited by 7
- K223541: Cold/Hot Compression (2023), cited by 2
- K153520: Electronic Pulse Stimulator (2016), cited by 2
- K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch (2020), cited by 1

## Recent decisions
- K253150: Cryon-X Cold Compression (Oct 24, 2025)
- K240788: Ultrasound Stimulator (Jun 4, 2025)
- K240986: Cold Compression (May 1, 2024)
- K240011: Lymphedema Compression (Feb 23, 2024)
- K223541: Cold/Hot Compression (Oct 27, 2023)
- K211050: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (Nov 28, 2022)
- K202839: Overlapped Compression Therapy (Jan 21, 2021)
- K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch (Jul 1, 2020)

Source page: https://510kreport.com/company/jkh-health