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FDA 510(k)

Combo Electrotherapy Device

K-Number: K231440 · 2023-11-03

ApplicantShenzhen Roundwhale Technology Co. , Ltd.
Decision Date2023-11-03
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Combo Electrotherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231440. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Combo Electrotherapy Device?

Combo Electrotherapy Device is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K231440.

When did Combo Electrotherapy Device receive FDA 510(k) clearance?

Combo Electrotherapy Device received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231440.

Who is the listed applicant for Combo Electrotherapy Device?

The FDA 510(k) record lists Shenzhen Roundwhale Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Combo Electrotherapy Device?

The FDA product code for Combo Electrotherapy Device is IPF.

Other records listing Shenzhen Roundwhale Technology Co. , Ltd. 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.

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; ElectrotheK222252Self-adhesive ElectrodeK192087Combo Electrotherapy DeviceK181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorK180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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