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510(k) Data Aggregation
K Number
K243856Device Name
TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
Manufacturer
Shenzhen AsTec Technology Co., Ltd.
Date Cleared
2025-05-29
(164 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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K Number
K250360Device Name
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
Manufacturer
Shenzhen Jiantuo Electronics Co., Ltd.
Date Cleared
2025-05-11
(90 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
Not Found
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K Number
K250053Device Name
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
Manufacturer
Shenzhen Jiantuo Electronics Co., Ltd.
Date Cleared
2025-05-09
(119 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
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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?
Product Code :
NUH
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
K250033Device Name
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
Manufacturer
Guangzhou Pinzhi Medical Technology Co., LTD
Date Cleared
2025-04-07
(90 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PZ-2622 is TENS and EMS Stimulator
Mode 1-12: TENS: This mode 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
PZ-2622E (Mode 1-24) is EMS Stimulator
This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
PZ-2622T (Mode 1-24) is TENS Stimulator
This 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
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K Number
K242460Device Name
Progenix Select Stim
Manufacturer
Progenix LLC
Date Cleared
2025-04-02
(226 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain.
The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time.
The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.
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K Number
K242815Device Name
POCKET TENS (EP-300)
Manufacturer
HIVOX BIOTEK INC.
Date Cleared
2024-12-17
(90 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.
TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.
This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.
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K Number
K243334Device Name
Nooro Body & Foot Stimulator (SM9141, SM9142)
Manufacturer
XF Agencija Limited
Date Cleared
2024-11-22
(29 days)
Product Code
NUH, GZJ, IPF, NGX, NYN
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-The-Counter Use:
TENS:
The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS/NMES:
The device (SM9141, SM9142) is used to stimulate healthy muscles in order to improve and facilitate muscle performance.
To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, feet and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
The device (SM9141, SM9142) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
Device (SM9141, SM9142):
TENS:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
EMS/NMES:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Device Description
Not Found
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K Number
K242332Device Name
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
Manufacturer
Shenzhen Kentro Medical Electronics Co., Ltd.
Date Cleared
2024-11-05
(90 days)
Product Code
NUH, NYN
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.
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
Changsha Anxiang Medical Technology Co., Ltd.
Date Cleared
2024-11-04
(67 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Product Code :
NUH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Not Found
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