The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for Inf 4160, Model D-fj27f.
| Device ID | K043407 |
| 510k Number | K043407 |
| Device Name: | INF 4160, MODEL D-FJ27F |
| Classification | Interferential Current Therapy |
| Applicant | FUJI DYNAMICS LIMITED LIYATONG INDUSTRIAL DISTRICT LIN CHUN, TANG XIA Dong Guan, Guangdong, CN |
| Contact | Anthony Ah Yin Shum |
| Correspondent | Anthony Ah Yin Shum FUJI DYNAMICS LIMITED LIYATONG INDUSTRIAL DISTRICT LIN CHUN, TANG XIA Dong Guan, Guangdong, CN |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-02-11 |
| Summary: | summary |