FDA 510(k)

Combo Electrotherapy Device

Número K: K231440 · 2023-11-03

RequerenteShenzhen Roundwhale Technology Co. , Ltd.

Data da decisão2023-11-03

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Shenzhen Roundwhale Technology Co. , Ltd. como candidato(a)

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 K222252Self-adhesive Electrode K192087Combo Electrotherapy Device 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

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Fonte oficial

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