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FDA 510(k)

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

K-Number: K180956 · 2018-06-07

ApplicantShenzhen Roundwhale Technology Co. , Ltd.
Decision Date2018-06-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is a medical device manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-06-07 under approval number K180956. 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 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K180956.

When was Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator approved by the FDA?

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-06-07, under approval number K180956.

What company makes Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is manufactured by Shenzhen Roundwhale Technology Co. , Ltd..

What is the FDA product code for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

The FDA product code for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is NUH.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT07569705 Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING

Other Devices by Shenzhen Roundwhale Technology Co. , Ltd.

K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; 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) K232995Neurological 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

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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.

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