BTL-699— 510(k) K260691
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K260691 for BTL-699, Substantially Equivalent on 2026-08-23. Applicant: BTL Industries, Inc.. Device class: 2.
Summary
BTL Industries' BTL-699 is filed under product code OBP, transcranial magnetic stimulators. The name is a model designation, and the record has no other description.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
BTL filed from Marlborough, Massachusetts. The decision came 173 calendar days after receipt (March 3 to August 23, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code OBP
view all- K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
- K261228 — QuickVision Ultimate rTMS
- K260189 — MagVenture Accelerated TMS (aTMS) Therapy System
- K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System
- K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
More clearances from BTL Industries, Inc.
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.