510(k) K021359
K021359 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare, Inc. for the device "DIGI-PRO TENS MODEL WL-2203 AND WL-2205". The FDA issued a decision of Substantially Equivalent on April 30, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Well-Life Healthcare, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2002
- Date Received
- January 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type