510(k) K070890
K070890 is an FDA 510(k) premarket notification submitted by Everlife Medical Equipment Co., Ltd. for the device "EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Everlife Medical Equipment Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2007
- Date Received
- March 30, 2007
- Clearance Type
- Traditional
- 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