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510(k) Data Aggregation
K Number
K150995Device Name
Electronic Pulse Stimulator
Manufacturer
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
Date Cleared
2015-07-06
(82 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Device Description
Not Found
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K Number
K141260Device Name
ELECTRONIC PULSE STIMULATOR
Manufacturer
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
Date Cleared
2014-09-17
(125 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Device Description
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
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K Number
K131921Device Name
ELECTRONIC PULSE STIMULATOR
Manufacturer
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
Date Cleared
2013-11-15
(142 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
Device Description
The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
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