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)

Health Expert Electronic Stimulator (model: AST-300L)

K-Number: K190783 · 2020-03-14

ApplicantShenzhen Osto Technology Company Limited
Decision Date2020-03-14
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Health Expert Electronic Stimulator (model: AST-300L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2020-03-14 under 510(k) number K190783. 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 (model: AST-300L)?

Health Expert Electronic Stimulator (model: AST-300L) is a medical device that received FDA 510(k) clearance on 2020-03-14. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K190783.

When did Health Expert Electronic Stimulator (model: AST-300L) receive FDA 510(k) clearance?

Health Expert Electronic Stimulator (model: AST-300L) received FDA 510(k) clearance on 2020-03-14, under 510(k) number K190783.

Who is the listed applicant for Health Expert Electronic Stimulator (model: AST-300L)?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health Expert Electronic Stimulator (model: AST-300L)?

The FDA product code for Health Expert Electronic Stimulator (model: AST-300L) is NUH.

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.

NCT07647159Voice Assistant for Outpatient Neurology VisitsCOMPLETEDNCT07202104Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic StethoscopesWITHDRAWN

Other records listing Shenzhen Osto Technology Company Limited as applicant

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.

K213056LED Facial MaskK211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)K212989Low-frequency Stimulator (Model: AST-645, AST-646)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-905HK190673Health Expert Electronic Stimulator

View all 11 devices →

Related Devices (Code: NUH)

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.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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.

↑