510(k) K071320
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 by
Everlife Medical Equipment Co., Ltd.
— Product Code IPF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2007
- Date Received
- May 10, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type