Source: https://tmscenterofswfl.com/u-s-food-drug-administration-letter-regarding-mag-vita-tms-therapy-system-w-theta-burst-stimulation/
Timestamp: 2018-09-24 11:34:55
Document Index: 279459562

Matched Legal Cases: ['arts 800', 'art 807', 'art\n801', 'art 820', 'art\n807', 'art\n803']

U.S. Food & Drug Administration Letter Regarding Mag Vita TMS Therapy System w/Theta Burst Stimulation - TMS Center SWFL
post-title U.S. Food & Drug Administration Letter Regarding Mag Vita TMS Therapy System w/Theta Burst Stimulation https://tmscenterofswfl.com/wp-content/uploads/si-FDA.jpg 2018-08-15 18:25:35 yes no Posted by tmscenter
This Letter Shows that TBS is FDA Approved Tonica Elektronik A/S Sanne Jessen Medical Advisor Lucernemarken 15 Farum, 3520 Dk Re: K173620 Trade/Device Name: Mag Vita TMS Therapy System w/Theta Burst Stimulation Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: July 10, 2018 […]
You are here: Home \ U.S. Food & Drug Administration Letter Regarding Mag Vita TMS Therapy System w/Theta Burst Stimulation
This Letter Shows that TBS is FDA Approved
Sanne Jessen
Farum, 3520 Dk
Re: K173620
Trade/Device Name: Mag Vita TMS Therapy System w/Theta Burst Stimulation
Regulation Number: 21 CFR 882.5805
Dear Sanne Jessen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act’s
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
[Read the Original Letter from the FDA Here]