DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B— 510(k) K030537
Substantially EquivalentWell-Life Healthcare, Inc.
FDA 510(k) clearance K030537 for DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B, Substantially Equivalent on 2003-03-20. Applicant: Well-Life Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Well-Life Healthcare, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung, R.O.C., TW
Recent devices under product code GZJ
view allMore clearances from Well-Life Healthcare, Inc.
view all- K040512 — LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
- K033857 — T-TECH DIGITAL, MODEL WL-22XXA SERIES
- K020020 — THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
- K020314 — DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
- K021359 — DIGI-PRO TENS MODEL WL-2203 AND WL-2205
Data sourced from openFDA. This site is unofficial and independent of the FDA.