510(k) K181207
K181207 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co., Ldt. for the device "Balego TENS Digital Edition with Accessories for Pain Relief (OTC)". The FDA issued a decision of Substantially Equivalent on Jun 6, 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
- Jun 6, 2018
- Date Received
- May 7, 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