510(k) K192234
K192234 is an FDA 510(k) premarket notification submitted by Bioelectronics Corporation for the device "ActiPatch". The FDA issued a decision of Substantially Equivalent on January 31, 2020. The device falls under product code PQY (Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain), a Class II device regulated under 21 CFR 890.5290. Bioelectronics Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2020
- Date Received
- August 19, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.