FDA 510(k)

Ova+ (K-OVAP-USA)

Numéro K : K230926 · 2023-12-15

Date de décision2023-12-15

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Ova+ (K-OVAP-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230926. 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 Ova+ (K-OVAP-USA)?

Ova+ (K-OVAP-USA) is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Tenscare, Ltd.. The 510(k) number is K230926.

When did Ova+ (K-OVAP-USA) receive FDA 510(k) clearance?

Ova+ (K-OVAP-USA) received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230926.

Who is the listed applicant for Ova+ (K-OVAP-USA)?

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

What is the FDA product code for Ova+ (K-OVAP-USA)?

The FDA product code for Ova+ (K-OVAP-USA) is NUH.

Autres dossiers indiquant Tenscare, Ltd. en tant que demandeur

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.

K232441Unipro (K-UNIPRO-US)K230983Unicare (K-UNICARE-USA)K231053Unicare (K-UNICARE-USA)K200694Perfect EMS K191312Perfect PFE

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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