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 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 2018-06-07 under 510(k) 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. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K180956.

When did Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator receive FDA 510(k) clearance?

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 510(k) number K180956.

Who is the listed applicant for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model 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 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.

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

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Related Devices (Code: NUH)

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.