510(k) clearances

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Shenzhen Roundwhale Technology Co. , Ltd. · Neurology

K231423Substantially EquivalentTraditionalNUH
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Neurology
Address 1
202,2/F,Bldg. 27, Dafa Industrial Park, Longxi Community,
Address 2
Longgang St., Longgang District
Statement or summary
Summary
Product code
NUH
Zip code
518108
Applicant
Shenzhen Roundwhale Technology Co. , Ltd.
Decision date
2024-01-22
Decision code
SESE
Country code
CN
Device name
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
Advisory committee
NE
Contact
Zeng Chunming
K number
K231423
Date received
2023-05-17
Review advisory committee
NE
Postal code
518108
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Medical specialty description
Neurology
Regulation number
882.5890
Device class
2
Registration number
3015007456, 3015214304, 3010880718, 3007719656, 3026322014, 3010097863, 3023613474, 3005170249, 3012840029, 8030245, 3008806536, 3025367760, 3012651177, 3030412027, 3017887847, 3038295706, 3006367638, 2248223, 3007615436, 3010894709, 3012729332, 3006850006, 3004183512, 3010078417, 3025235024, 3014647250, 9611558, 3012134907, 3009437400, 3003741676, 3009411292, 3018940143, 9616086, 3011767724, 3016452327, 3005569927, 3008973759, 3030597665, 3016856381, 3042190125 +131 more
FEI number
3015007456, 3015214304, 3010880718, 3007719656, 3026322014, 3010097863, 3006076154, 3023613474, 3005170249, 3012840029, 1000126561, 3008806536, 3025367760, 3012651177, 3030412027, 3017887847, 3038295706, 3006367638, 3007615436, 3010894709, 3012729332, 3006850006, 3004183512, 3010078417, 3025235024, 3014647250, 3012134907, 3009437400, 3003741676, 3009411292, 3018940143, 1000122747, 3003255512, 3011767724, 3016452327, 3005569927, 3008973759, 3003499891, 3030597665, 3042190125 +131 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.