MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00— 510(k) K051864
Substantially EquivalentThe Magstim Company , Ltd.
FDA 510(k) clearance K051864 for MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00, Substantially Equivalent on 2005-12-21. Applicant: The Magstim Company , Ltd.. Device class: 2.
Clearance details
- Applicant
- The Magstim Company , Ltd.
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whitland, Dyfed Wales, GB
Recent devices under product code GWF
view allMore clearances from The Magstim Company , Ltd.
view allAdverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
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 →
Recalls naming K051864
K-number listed on FDA's recall record- Z-1965-2020 — Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
- Z-1966-2020 — Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051864.
Data sourced from openFDA. This site is unofficial and independent of the FDA.