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510(k) Data Aggregation
K Number
K251706Device Name
TENS and EMS Unit
Manufacturer
Date Cleared
2025-07-30
(57 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.
Device Description
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K Number
K251187Device Name
3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
Manufacturer
Date Cleared
2025-07-28
(102 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
**1) TENS**
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
**2) EMS**
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
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K Number
K250759Device Name
3 in 1 TENS UNIT
Manufacturer
Date Cleared
2025-06-13
(92 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
**1) TENS**
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
**2) EMS**
The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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K Number
K243763Device Name
Wireless TENS & EMS Unit
Manufacturer
Date Cleared
2025-03-12
(96 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
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K Number
K243511Device Name
OTC TENS & EMS Unit
Manufacturer
Date Cleared
2025-02-10
(90 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, wast, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.
Device Description
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K Number
K242787Device Name
Tens & Ems Device (TU1080)
Manufacturer
Date Cleared
2024-12-18
(93 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen, and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
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K Number
K242567Device Name
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
Manufacturer
Date Cleared
2024-11-04
(67 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Changsha Anxiang Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
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