510(k) clearances

OTC TENS & EMS Unit

Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

K243511Substantially EquivalentTraditionalNGX
Open FDA's page for this record
Third party flag
N
City
Changsha
Advisory committee description
Physical Medicine
Address 1
9th Floor, R&D Center And Supporting Projects 101
Address 2
# 18 Shaoshan Middle Rd., Dongtang St. Yuhua District
Statement or summary
Statement
Product code
NGX
Zip code
410000
Applicant
Changsha Anxiang Medical Technology Co., Ltd.
Decision date
2025-02-10
Decision code
SESE
Country code
CN
Device name
OTC TENS & EMS Unit
Advisory committee
PM
Contact
William Fu
K number
K243511
Date received
2024-11-12
Review advisory committee
PM
Postal code
410000
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.