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FDA 510(k)

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

K-Number: K230443 · 2023-05-22

ApplicantJiangxi Royall Smart Technology Co., Ltd.
Decision Date2023-05-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Royall Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230443. 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 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Jiangxi Royall Smart Technology Co., Ltd.. The 510(k) number is K230443.

When did TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) receive FDA 510(k) clearance?

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230443.

Who is the listed applicant for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

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

What is the FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

The FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) 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

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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