510(k) K092763
K092763 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare Limited for the device "IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D". The FDA issued a decision of Substantially Equivalent on October 8, 2009. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Well-Life Healthcare Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2009
- Date Received
- September 9, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interferential Current Therapy
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type