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510(k) Data Aggregation
K Number
K172450Device Name
TENS device-HeadaTerm, eEspress
Manufacturer
WAT Medical Technology (Ningbo) Co., Ltd
Date Cleared
2018-09-13
(395 days)
Product Code
PCC
Regulation Number
882.5891Why did this record match?
Applicant Name (Manufacturer) :
WAT Medical Technology (Ningbo) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Device Description
TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device-HeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.
The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.
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K Number
K172478Device Name
TENS device-EmeTerm, CinvStop
Manufacturer
WAT Medical Technology (Ningbo) Co., Ltd
Date Cleared
2018-04-19
(246 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WAT Medical Technology (Ningbo) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EmeTerm CinvStop is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
Device Description
TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient's wrist.
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