FDA 510(k)

Nooro Body & Foot Stimulator (SM9141, SM9142)

Numéro K : K243334 · 2024-11-22

Date de décision2024-11-22

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd 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

Source officielle

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