510(k) K003487
K003487 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "STIMATE N601 TENS". The FDA issued a decision of Substantially Equivalent on Jan 24, 2001. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Everyway Medical Instruments Co.,Ltd has 28 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2001
- Date Received
- Nov 13, 2000
- 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
- 510(k)