Clearance Summary
FitRelief TENS&EMS Wireless Device received FDA 510(k) clearance under submission number K191938, sponsored by Heat IN A Click, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-08-28.
- Submission: K191938
- Applicant / Sponsor: Heat IN A Click, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2020-08-28
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.