Rapid2 Therapy System— 510(k) K162935
Substantially EquivalentMagstim Company, Ltd.
FDA 510(k) clearance K162935 for Rapid2 Therapy System, Substantially Equivalent on 2017-03-10. Applicant: Magstim Company, Ltd.. Device class: 2.
Clearance details
- Applicant
- Magstim Company, Ltd.
- Product code
- 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
- Whitland, GB
Recent devices under product code OBP
view allMore clearances from Magstim Company, Ltd.
view all- K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
- K203684 — Neurosign V4 Intraoperative Nerve Monitor
- K183376 — HORIZON TMS Therapy System with Navigation
Adverse 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 →
Recalls naming K162935
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.
- Z-1352-2018 — Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders 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 K162935.
Data sourced from openFDA. This site is unofficial and independent of the FDA.