Anthony “Tony” E. Picciano
Owner/President
Neurotris, Inc. dba A1 Engineering
30 Mauchly Ste A
Irvine , CA 92618
United States
tony@neurotris.comFEI 3008069988Issued Oct 27, 2023Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008069988.
Violations10
Issue DateOct 27, 2023
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Neurotris, Inc. dba A1 Engineering
Location
Anthony “Tony” E. Picciano
Owner/President
Neurotris, Inc. dba A1 Engineering
30 Mauchly Ste A
Irvine , CA 92618
United States
tony@neurotris.com
FEI Number
3008069988
Country
United States
Issue Date
October 27, 2023
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Neurotris, Inc. dba A1 Engineering manufactured and distributed Class II Powered Muscle Stimulator devices (including the SX2500 Picowave, SX3800, SX4500, SVX650, and PICO Toner models) without required premarket approval (PMA) or 510(k) clearance, rendering the products adulterated and misbranded under federal law. An FDA inspection conducted April 4-25, 2023 identified these violations, and the company's May 6, 2023 response was found inadequate to address the deficiencies. The devices were being marketed and distributed for medical purposes including muscle stimulation and body treatment without the necessary regulatory authorization.
Neurotris, Inc. dba A1 Engineering FDA Warning Letter, October 27, 2023
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