510(k) K884972
K884972 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR". The FDA issued a decision of Substantially Equivalent on July 27, 1989. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1989
- Date Received
- November 30, 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