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)

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

K-Number: K232995 · 2024-01-11

ApplicantShenzhen Roundwhale Technology Co. , Ltd.
Decision Date2024-01-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is a medical device manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2024-01-11 under approval number K232995. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K232995.

When was Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe approved by the FDA?

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe received FDA 510(k) clearance on 2024-01-11, under approval number K232995.

What company makes Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is manufactured by Shenzhen Roundwhale Technology Co. , Ltd..

What is the FDA product code for Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

The FDA product code for Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is GXY.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04456569 Geniculate Artery Embolization for Osteoarthritis ACTIVE_NOT_RECRUITING NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED

Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026)

Other Devices by Shenzhen Roundwhale Technology Co. , Ltd.

K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator K192087Combo Electrotherapy Device K231440Combo Electrotherapy Device K222252Self-adhesive Electrode K231423Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

View all 7 devices →

Related Devices (Code: GXY)

K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2WMedico Electrodes International , Ltd. K160081TENS ElectrodesCathay Manufacturing Corp. K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc. K152815Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd. K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd

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.

↑