FDA 510(k)

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

Número K: K181688 · 2018-09-07

RequerenteShenzhen Roundwhale Technology Co. , Ltd.

Data da decisão2018-09-07

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator 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 2018-09-07 under 510(k) number K181688. 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 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K181688.

When did R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator receive FDA 510(k) clearance?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181688.

Who is the listed applicant for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

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 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

The FDA product code for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is IPF.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K231440Combo Electrotherapy Device K222252Self-adhesive Electrode K192087Combo Electrotherapy Device K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: IPF)

K253542Quattro Apollo (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati K260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.