Clearance Summary
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 received FDA 510(k) clearance under submission number K020314, sponsored by Well-Life Healthcare, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2002-04-30.
- Submission: K020314
- Applicant / Sponsor: Well-Life Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2002-04-30
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.