# Fuji Dynamics Limited

- Location (FDA's records): Hong Kong, CN
- FDA decisions: 12 (2000–2016): 12 510(k) clearances
- Names in FDA's records: Fuji Dynamics Limited (7); Fuji Dynamics , Ltd. (5)
- Product codes: GZJ (7), LIH (2), KPI (1), IPF (1), NUH (1)
- 510(k) review time since 2016: median 126 days, against 145 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 10 (5 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
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Biomedical Life Systems, Inc.: 2 (https://510kreport.com/company/biomedical-life-systems)
- Wholesale Medical Imports, Inc.: 2 (https://510kreport.com/company/wholesale-medical-imports)
- Body Clock Health Care, Ltd.: 1 (https://510kreport.com/company/body-clock-health-care)

## Firms that cite its devices most
- Kingfisher Healthcare NV: 1 (https://510kreport.com/company/kingfisher-healthcare)
- Top-Rank Health Care Co., Ltd.: 1 (https://510kreport.com/company/top-rank-health-care)
- Shenzhen Med-Link Electronics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-med-link-electronics-tech)
- Tenscare, Ltd.: 1 (https://510kreport.com/company/tenscare)
- Easy Med Instrument Co., Ltd.: 1 (https://510kreport.com/company/easy-med-instrument)

## Its most-cited devices
- K994266: Fdtens 2010 (2000), cited by 4
- K052813: FD Tens 2030, Model DFJ24T (2006), cited by 2
- K161055: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (2016), cited by 1
- K063642: FD Ems, Model # D-FJ30E (2007), cited by 1
- K994265: Medisana Digital Tens (2000), cited by 1
- K152374: LL Tens 160A, LL Tens 160B (2016), cited by 1

## Recent decisions
- K161055: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (Jul 12, 2016)
- K152676: FD Tens 2090, FD Tens 2095 (Jan 22, 2016)
- K152374: LL Tens 160A, LL Tens 160B (Jan 13, 2016)
- K111654: FD Tens 2070 (Mar 1, 2012)
- K111645: FD Tens 2050 or Slide Tens Model FD2050 (Nov 9, 2011)
- K092780: Inf 4160 Plus, Model D-FJ31F (Jan 7, 2010)
- K063642: FD Ems, Model # D-FJ30E (Dec 13, 2007)
- K052813: FD Tens 2030, Model DFJ24T (Jan 25, 2006)

Source page: https://510kreport.com/company/fuji-dynamics