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510(k) Data Aggregation
K Number
K243613Device Name
Patch-TEA (Model TRI-21)
Manufacturer
Transtimulation Research, Inc
Date Cleared
2025-04-09
(138 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Transtimulation Research, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
Device Description
The Patch-TEA device is a non-invasive, battery-operated, over-the-counter transcutaneous electrical nerve field stimulator indicated for use in adult patients for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
The system includes the following components: Patch-TEA device, charging case, electrode pads, USB charging cable, and Patch-TEA app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home.
The Patch-TEA device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The Patch-TEA device is able to connect with the Patch-TEA app, which is located on a smartphone. The user interface is available on both the Patch-TEA device and Patch-TEA app. The user can power on/off the device, adjust treatment time and treatment intensity.
Treatment time is adjustable within the of range 5~240 minutes per treatment session. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the Patch-TEA device and Patch-TEA app located on a smartphone.
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K Number
K230526Device Name
TEA Device
Manufacturer
Transtimulation Research, Inc.
Date Cleared
2023-09-14
(199 days)
Product Code
QHH
Regulation Number
876.5340Why did this record match?
Applicant Name (Manufacturer) :
Transtimulation Research, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
Device Description
The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
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