510(k) K880492
K880492 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "INTERCEPT T.E.N.S. DEVICE". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1988
- Date Received
- February 4, 1988
- Clearance Type
- Traditional
- 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