510(k) K113010
K113010 is an FDA 510(k) premarket notification submitted by Famidoc Technology Co., Ltd. for the device "FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR". The FDA issued a decision of Substantially Equivalent on Dec 21, 2012. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Famidoc Technology Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 21, 2012
- Date Received
- Oct 11, 2011
- 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
- 510(k)