Ampa One System (AMPA-001)— 510(k) K251210

Name: FDA 510(k) clearance K251210
Creator: U.S. Food and Drug Administration
Published: 2025-06-27

Substantially Equivalent

Neuromodulatory Devices & Applications

FDA 510(k) clearance K251210 for Ampa One System (AMPA-001), Substantially Equivalent on 2025-06-27. Applicant: Neuromodulatory Devices & Applications. Device class: 2.

Clearance details

Applicant: Neuromodulatory Devices & Applications
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2025-04-18
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.