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SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30143149333014314933SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.1N2026-01-01202,2/F, Building 27, Dafa Industrial Park, Longxi Community Longgang Street, Longgang District Shenzhen Guangdong CN 518116

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2163291650070649K232995Neurological 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; ElectrotheGXY2024-01-11
2163291736853006K231440Combo Electrotherapy DeviceIPF2023-11-03
2163292058191520K231423Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)NUH2024-01-22
2163291289249893K222252Self-adhesive ElectrodeGXY2023-01-19
2163291896458768K192087Combo Electrotherapy DeviceNUH2019-11-01
2163291594079022K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorIPF2018-09-07
2163291979450407K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS StimulatorNUH2018-06-07
2163291063601866
2163291605514712

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUH42024-01-22
IPF32023-11-03
GXY22024-01-11

GUDID#

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