510(k) K250309
K250309 is an FDA 510(k) premarket notification submitted by BTL Industries, Inc. for the device "BTL-199". The FDA issued a decision of Substantially Equivalent on August 7, 2025. The device falls under product code QPL (Electromagnetic Stimulator, Pain Relief), a Class II device regulated under 21 CFR 882.5890. BTL Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2025
- Date Received
- February 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromagnetic Stimulator, Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- PM
- Submission Type
Intended to apply a magnetic-field induced electrical current to treat pain.