This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | 2016-07-12 |
| US | K152676 | FD TENS 2090, FD TENS 2095 | 2016-01-22 |
| US | K152374 | LL TENS 160A, LL TENS 160B | 2016-01-13 |
| CA | 65696 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS (TENS) | Class II |