510(k) clearances

Pain Therapy Device(Model: P.T.S-X)

Guangzhou Xinbo Electronic Co., Ltd. · Physical Medicine

K230711Substantially EquivalentTraditionalNGX
Open FDA's page for this record
Third party flag
N
City
Guangzhou
Advisory committee description
Physical Medicine
Address 1
#23 Bldg., The Second Phase,
Address 2
Huachuang Animation Industry Park, Panyu,
Statement or summary
Statement
Product code
NGX
Zip code
511450
Applicant
Guangzhou Xinbo Electronic Co., Ltd.
Decision date
2024-05-16
Decision code
SESE
Country code
CN
Device name
Pain Therapy Device(Model: P.T.S-X)
Advisory committee
PM
Contact
Sammy Li
K number
K230711
Date received
2023-03-15
Review advisory committee
PM
Postal code
511450
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Muscle, Powered, For Muscle Conditioning
Medical specialty description
Physical Medicine
Regulation number
890.5850
Device class
2
Registration number
3015007456, 3015214304, 3033844600, 3010880718, 3004081884, 3026322014, 3010097863, 3016832824, 3009102830, 3023613474, 3005170249, 3008345424, 3012840029, 3008806536, 3025367760, 3012651177, 3030412027, 1061158, 3013423303, 3015452693, 3017887847, 3038295706, 3007615436, 3012729332, 3006850006, 3004183512, 3015282440, 3010078417, 3025235024, 3014647250, 1054713, 3026400760, 3035374386, 9611558, 3012134907, 3009437400, 3015529344, 3010385841, 3010427504, 3007120647 +171 more
FEI number
3015007456, 3015214304, 3033844600, 3010880718, 3004081884, 3026322014, 3010097863, 3016832824, 3006076154, 3009102830, 3023613474, 3005170249, 3008345424, 3002808188, 3012840029, 3008806536, 3025367760, 3012651177, 3030412027, 3013423303, 3015452693, 3017887847, 3038295706, 3007615436, 3012729332, 3006850006, 3004183512, 3015282440, 3010078417, 3025235024, 3014647250, 3026400760, 3035374386, 3012134907, 3009437400, 3015529344, 3010385841, 3010427504, 3007120647, 3018940143 +171 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.