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FDA 510(k)

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

Numéro K : K232995 · 2024-01-11

DemandeurShenzhen Roundwhale Technology Co. , Ltd.
Date de décision2024-01-11
Code produitGXY
Comité consultatifNE
DécisionSubstantially Equivalent

Résumé du dispositif

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K232995. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K232995.

When did Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe receive FDA 510(k) clearance?

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe received FDA 510(k) clearance on 2024-01-11, under 510(k) number K232995.

Who is the listed applicant for Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

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

What is the FDA product code for Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe?

The FDA product code for Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe is GXY.

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Autres dossiers indiquant Shenzhen Roundwhale Technology Co. , 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.

K231423Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)K231440Combo Electrotherapy DeviceK222252Self-adhesive ElectrodeK192087Combo Electrotherapy DeviceK181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorK180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Voir tous les 7 dispositifs →

Dispositifs connexes (Code : GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Modèles 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Modèles 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Modèles 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

Source officielle

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