510(k) K020032
K020032 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL MINI TENS". The FDA issued a decision of Substantially Equivalent on Jan 31, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Apex Medical Corp. has 35 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2002
- Date Received
- Jan 4, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)