The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for Inf 4160 Plus, Model D-fj31f.
| Device ID | K092780 |
| 510k Number | K092780 |
| Device Name: | INF 4160 PLUS, MODEL D-FJ31F |
| Classification | Interferential Current Therapy |
| Applicant | FUJI DYNAMICS LIMITED 23/F., UNIT 1-3, 788 CHEUNG SHA WAN ROAD Kowloon, Hong Kong, CN |
| Contact | Ching Kong Lee |
| Correspondent | Ching Kong Lee FUJI DYNAMICS LIMITED 23/F., UNIT 1-3, 788 CHEUNG SHA WAN ROAD Kowloon, Hong Kong, CN |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-10 |
| Decision Date | 2010-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04897079950017 | K092780 | 000 |