BTL-699— 510(k) K260691

Name: FDA 510(k) clearance K260691
Creator: U.S. Food and Drug Administration
Published: 2026-08-23

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K260691 for BTL-699, Substantially Equivalent on 2026-08-23. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2026-03-03
Decision date: 2026-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.