Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K

K-Number: K220177 · 2022-09-01

ApplicantMagnus Medical, Inc.
Decision Date2022-09-01
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is the device name listed in this FDA 510(k) record. The listed applicant is Magnus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220177. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Magnus Medical, Inc.. The 510(k) number is K220177.

When did Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K receive FDA 510(k) clearance?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220177.

Who is the listed applicant for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

The FDA 510(k) record lists Magnus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

The FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is OBP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07210255SAINT in Postpartum Depression (PPD)RECRUITINGNCT07222449Wearables-and Blood-based Biomarkers-incorporated Modernisation of Circadian Rhythm Disruption Management in People Living With Alzheimer's Dementia: A Stepwise Study From Digital Inclusivity, Digital Therapy, to Digital Phenotyping and Biomarker ExplorationENROLLING_BY_INVITATIONNCT07288593INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity InterventionNOT_YET_RECRUITINGNCT07508722Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in HumansNOT_YET_RECRUITINGNCT07775586Home-Based Wearable rTMS Therapy for Moderate to Severe DepressionNOT_YET_RECRUITING

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑