The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for L-tens.
| Device ID | K041164 |
| 510k Number | K041164 |
| Device Name: | L-TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUJI DYNAMICS LIMITED UNIT 1-3, LAWS COMMERCIAL PLAZA 788 CHEUNG SHA WAN RD. Hong Kong, CN |
| Contact | Anthony Ah Yin, Shum |
| Correspondent | Anthony Ah Yin, Shum FUJI DYNAMICS LIMITED UNIT 1-3, LAWS COMMERCIAL PLAZA 788 CHEUNG SHA WAN RD. Hong Kong, CN |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060079211733 | K041164 | 000 |
| 05060079211283 | K041164 | 000 |
| 05060079210675 | K041164 | 000 |
| 05060079210217 | K041164 | 000 |