The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for Fd Tens 2030, Model Dfj24t.
| Device ID | K052813 |
| 510k Number | K052813 |
| Device Name: | FD TENS 2030, MODEL DFJ24T |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUJI DYNAMICS LIMITED 788 CHEUNG SHA WAN RD.UNIT 1-3 23/F, LAWS COMMERCIAL PLAZA Kowloon, HK |
| Contact | Anthony Ah Yin Shun |
| Correspondent | Anthony Ah Yin Shun FUJI DYNAMICS LIMITED 788 CHEUNG SHA WAN RD.UNIT 1-3 23/F, LAWS COMMERCIAL PLAZA Kowloon, HK |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2006-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060079210101 | K052813 | 000 |