510(k) K181849
K181849 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co., Ldt. for the device "iStim S2 OTC Pain Relief TENS". The FDA issued a decision of Substantially Equivalent on Aug 10, 2018. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Everyway Medical Instruments Co., Ldt. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 2018
- Date Received
- Jul 11, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES