The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for T-tech Digital, Model Wl-22xxa Series.
| Device ID | K033857 |
| 510k Number | K033857 |
| Device Name: | T-TECH DIGITAL, MODEL WL-22XXA SERIES |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE HEALTHCARE, INC. 6C01, NO.5, SEC.5, HSIN YI RD. Taipei, TW 106 |
| Contact | Jenny Hsiah |
| Correspondent | Jenny Hsiah WELL-LIFE HEALTHCARE, INC. 6C01, NO.5, SEC.5, HSIN YI RD. Taipei, TW 106 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872262053 | K033857 | 000 |
| 04719872262046 | K033857 | 000 |
| 04719872262039 | K033857 | 000 |
| M368GFTX5EMS3 | K033857 | 000 |
| M368GFTX53 | K033857 | 000 |