The following data is part of a premarket notification filed by Well-life Consultant with the FDA for Well-tens.
| Device ID | K002874 |
| 510k Number | K002874 |
| Device Name: | WELL-TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE CONSULTANT 6CO1,NO.5.SEC.5,HSIN YI RD. Taipei, TW |
| Contact | Kevin Chiu |
| Correspondent | Kevin Chiu WELL-LIFE CONSULTANT 6CO1,NO.5.SEC.5,HSIN YI RD. Taipei, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-14 |
| Decision Date | 2001-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682891210074 | K002874 | 000 |
| M368GF33 | K002874 | 000 |
| M368GF3T3 | K002874 | 000 |
| M368LUMITENS2 | K002874 | 000 |
| M368SW10002 | K002874 | 000 |
| 04719872261025 | K002874 | 000 |
| 04719872261032 | K002874 | 000 |
| 00816864020111 | K002874 | 000 |
| 00816864020128 | K002874 | 000 |
| 00682891210043 | K002874 | 000 |
| M3682000T1 | K002874 | 000 |