Clearance Summary
BTL-094 received FDA 510(k) clearance under submission number K221865, sponsored by BTL Industries, Inc.. 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 2023-04-14.
- Submission: K221865
- Applicant / Sponsor: BTL Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 2023-04-14
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.