The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for The Izzzy-tens (wl-2401), The Slim-tens (wl-2402), The Mens-tens (wl2403), The Compact Tens (wl-2302).
| Device ID | K020020 |
| 510k Number | K020020 |
| Device Name: | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) |
| 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 Chang |
| Correspondent | Tony C 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 | 2002-01-03 |
| Decision Date | 2002-12-30 |
| Summary: | summary |