FDA 510(k)

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Numéro K : K253305 · 2025-12-31

DemandeurShenzhen Jiantuo Electronics Co., Ltd.

Date de décision2025-12-31

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jiantuo Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K253305. 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 TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Shenzhen Jiantuo Electronics Co., Ltd.. The 510(k) number is K253305.

When did TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) receive FDA 510(k) clearance?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) received FDA 510(k) clearance on 2025-12-31, under 510(k) number K253305.

Who is the listed applicant for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

The FDA 510(k) record lists Shenzhen Jiantuo Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

The FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) 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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Autres dossiers indiquant Shenzhen Jiantuo Electronics Co., Ltd. en tant que demandeur

K250360TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)K250053TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

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.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS BackDynapulse Medical

Source officielle

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