The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for Digi-pro Tens/wl-2203b,2204b,2204b-p1,2204b-p2,2205b.
| Device ID | K030537 |
| 510k Number | K030537 |
| Device Name: | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE HEALTHCARE, INC. NO. 5 ALLEY 5 LANE CHENG HSING CHUNG CHING RD., PEI TUN DIST. Taichung, TW |
| Contact | Tony C. S. Chang |
| Correspondent | Tony C. S. Chang WELL-LIFE HEALTHCARE, INC. NO. 5 ALLEY 5 LANE CHENG HSING CHUNG CHING RD., PEI TUN DIST. Taichung, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-03-20 |
| Summary: | summary |