Clearance Summary
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B received FDA 510(k) clearance under submission number K030537, sponsored by Well-Life Healthcare, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-03-20.
- Submission: K030537
- Applicant / Sponsor: Well-Life Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2003-03-20
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.