BTL-899TT— 510(k) K252963
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K252963 for BTL-899TT, Substantially Equivalent on 2026-06-12. Applicant: BTL Industries, Inc.. Device class: 2.
Summary
BTL Industries' BTL-899TT is filed under IMJ, shortwave diathermy for applying therapeutic deep heat. The record doesn't describe the device beyond the model number and the code name.
Class II, 21 CFR 890.5290. Physical Medicine is both the classification panel and the review panel, and the submission was a Traditional 510(k).
BTL filed from Marlborough, Massachusetts. Review took 268 calendar days (September 17, 2025 to June 12, 2026).
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Product code IMJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5290
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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