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

FDA 510(k)

Health Expert Electronic Stimulator

K-Number: K190673 · 2019-12-12

ApplicantShenzhen Osto Technology Company Limited
Decision Date2019-12-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Health Expert Electronic Stimulator is a medical device manufactured by Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2019-12-12 under approval number K190673. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Health Expert Electronic Stimulator?

Health Expert Electronic Stimulator is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Shenzhen Osto Technology Company Limited. The 510(k) number is K190673.

When was Health Expert Electronic Stimulator approved by the FDA?

Health Expert Electronic Stimulator received FDA 510(k) clearance on 2019-12-12, under approval number K190673.

What company makes Health Expert Electronic Stimulator?

Health Expert Electronic Stimulator is manufactured by Shenzhen Osto Technology Company Limited.

What is the FDA product code for Health Expert Electronic Stimulator?

The FDA product code for Health Expert Electronic Stimulator is NUH.

Related Clinical Trials

NCT07194317 A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment COMPLETED NCT07124247 Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation COMPLETED NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT07430358 Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence RECRUITING NCT07595185 Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder NOT_YET_RECRUITING NCT07592702 AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 41641793 Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024. Clinical trials (London, England) (2026)

Other Devices by Shenzhen Osto Technology Company Limited

K190783Health Expert Electronic Stimulator (model: AST-300L) K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H K213056LED Facial Mask

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb 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.

↑