The following data is part of a premarket notification filed by Fuji Dynamics Ltd with the FDA for Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15.
| Device ID | K161055 |
| 510k Number | K161055 |
| Device Name: | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Fuji Dynamics Ltd 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong, CN |
| Contact | Kam Tim Ng |
| Correspondent | Kam Tim Ng Fuji Dynamics Ltd 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong, CN |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2016-07-12 |
| Summary: | summary |