Specification developer and finished product manufacturer establishment: itovi (b)(4).Status: active; awaiting assignment of registration number; date of registration status: 2018; owner/operator: itovi (b)(4).Official correspondent: (b)(4), proprietary name: itovi; classification name: device, galvanic skin response measurement; product code: gzo; device class: 2; regulation number:(b)(4); medical specialty: neurology; [(b)(4)].
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From (b)(6) 2018- (b)(6) 2018, there were various discussions between the complainant and the formally designated complaint unit from the finished product manufacturer/ specification developer.During initial discussions on (b)(6) 2018, the complainant alleged to itovi's (the finished product manufacturer/ specification developer) formally designated complaint unit ((b)(4)) that on (b)(6) 2018, she (adult female) received an electric shock and heart palpitations (which also caused her to be passed out for an unknown amount of time also on (b)(6) 2018) while using the itovi device (i.E while scanning and having the unit be plugged into a power source).On (b)(6) 2018, the complainant sought medical attention due to the electric shock and heart palpitations.The subsequent (b)(6) 2018 medical record (copy supplied by the complainant) indicated that the complainant (who was alert and oriented three times) had lessening palpitations from the time of the incident, the complainant had no chest pain, coughing, dizziness, fever, malaise/fatigue, nausea, shortness of breath, vomiting or weakness during the (b)(6) 2018 medical examination.However, the medical record did not indicate whether the complainant required hospitalization and/or treatment for the alleged electric shock and heart palpitations.
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