510(k) K033253
K033253 is an FDA 510(k) premarket notification submitted by Micro Current Technology, Inc. for the device "S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Micro Current Technology, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2003
- Date Received
- October 8, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type