The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for Digi-pro Tens Model Wl-2203 And Wl-2205.
Device ID | K021359 |
510k Number | K021359 |
Device Name: | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 |
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 | 2002-01-30 |
Decision Date | 2002-04-30 |
Summary: | summary |