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FDA 510(k)

Nooro Body & Foot Stimulator (SM9141, SM9142)

K-Number: K243334 · 2024-11-22

ApplicantXf Agencija Limited
Decision Date2024-11-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nooro Body & Foot Stimulator (SM9141, SM9142) is the device name listed in this FDA 510(k) record. The listed applicant is Xf Agencija Limited. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K243334. 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 Nooro Body & Foot Stimulator (SM9141, SM9142)?

Nooro Body & Foot Stimulator (SM9141, SM9142) is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Xf Agencija Limited. The 510(k) number is K243334.

When did Nooro Body & Foot Stimulator (SM9141, SM9142) receive FDA 510(k) clearance?

Nooro Body & Foot Stimulator (SM9141, SM9142) received FDA 510(k) clearance on 2024-11-22, under 510(k) number K243334.

Who is the listed applicant for Nooro Body & Foot Stimulator (SM9141, SM9142)?

The FDA 510(k) record lists Xf Agencija Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nooro Body & Foot Stimulator (SM9141, SM9142)?

The FDA product code for Nooro Body & Foot Stimulator (SM9141, SM9142) 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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