510(k) K033140
K033140 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P". The FDA issued a decision of Substantially Equivalent on Oct 29, 2003. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Everyway Medical Instruments Co.,Ltd has 28 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2003
- Date Received
- Sep 30, 2003
- Clearance Type
- Special
- 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)