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FDA 510(k)

Smart Neck Stimulator

K-Number: K200558 · 2021-10-04

ApplicantGuandong Skg Intelligent Technology Co., Ltd.
Decision Date2021-10-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smart Neck Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K200558. 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 Smart Neck Stimulator?

Smart Neck Stimulator is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. The 510(k) number is K200558.

When did Smart Neck Stimulator receive FDA 510(k) clearance?

Smart Neck Stimulator received FDA 510(k) clearance on 2021-10-04, under 510(k) number K200558.

Who is the listed applicant for Smart Neck Stimulator?

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

What is the FDA product code for Smart Neck Stimulator?

The FDA product code for Smart Neck Stimulator is NUH.

Related Devices (Code: NUH)

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.

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 LimitedK251958VEINOPLUS 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.

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