510(k) K230782
K230782 is an FDA 510(k) premarket notification submitted by Wat Medical Technology, Inc. for the device "TENS device-HeadaTerm 2 (Model: YF-HT2)". The FDA issued a decision of Substantially Equivalent on February 26, 2024. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891. Wat Medical Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2024
- Date Received
- March 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Device Class
- Class II
- Regulation Number
- 882.5891
- Review Panel
- NE
- Submission Type
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.