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510(k) Data Aggregation
K Number
K230711Device Name
Pain Therapy Device(Model: P.T.S-X)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2024-05-16
(428 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pain Therapy Device (Model: P.T.S-X):
TENS (Transcutaneous electrical nerve stimulation):
- For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
- For relief of pain associated with arthritis.
- For symptomatic relief and management of chronic intractable pain
EMS (Electrical muscle stimulation):
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- To temporarily increase local blood circulation in healthy muscles.
NMES (Neuromuscular electrical stimulation):
- For relaxation of muscle spasm.
- Increase of blood flow circulation.
- Prevention or retardation of disuse muscle atrophy.
- Muscle re-education.
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Device Description
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K Number
K231789Device Name
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2024-03-11
(265 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII):
TENS
- For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
- For relief of pain associated with arthritis.
- For symptomatic relief and management of chronic intractable pain
EMS:
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- To temporarily increase local blood circulation in healthy muscles.
NMES:
- For relaxation of muscle spasm.
- Increase of blood flow circulation.
- Prevention or retardation of disuse muscle atrophy.
- Muscle re-education.
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet, NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Device Description
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K Number
K231164Device Name
Conductive carbon film electrode
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2023-08-09
(106 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower and upper back, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.
Device Description
Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact.
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K Number
K231167Device Name
Conductive Silicone Rubber Electrode
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2023-08-09
(106 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conductive silicone rubber electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive silicone rubber electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.
Device Description
Conductive Silicone Rubber Electrode
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K Number
K202671Device Name
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2021-11-12
(424 days)
Product Code
NUH, IRT, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DR-HO'S Back Pain Relief System Pro (Model: BPRS-1) is to be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
To stimulate healthy muscles in order to improve and facilitate muscle performance.
To temporarily increase local blood circulation in healthy muscles.
Heating Mode is to be used for temporary relief of minor aches and pains.
The DR-HO'S Back Pain Relief System Pro (Model: BPRS-II) is to be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
To stimulate healthy muscles in order to improve and facilitate muscle performance.
To temporarily increase local blood circulation in healthy muscles.
Device Description
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K Number
K212948Device Name
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2021-11-01
(46 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I): TENS: - For relief of pain and management of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves. - For relief of pain associated with arthritis. - For symptomatic relief and management of chronic intractable pain EMS: - To stimulate healthy muscles in order to improve and facilitate muscle performance. - To temporarily increase local blood circulation in healthy muscles. NMES: - For relaxation of muscle spasm. - Increase of blood flow circulation. - Prevention or retardation of disuse muscle atrophy. - Muscle re-education. - Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Device Description
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K Number
K202636Device Name
Metallic Fabric Electrodes
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2021-08-16
(339 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Metallic Fabric Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Metallic Fabric Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include wrist, elbow or arm, knee or leg and back band.
Device Description
Metallic Fabric Electrodes (Model A:Leg Band with Electrodes, Model B:Back Belt with Electrodes, Model C:Arm Band with Electrodes, Model D:Knee and lower lee band with Electrodes, Model F:Triple Action Back Belt with Electrodes, Model G:Leg Rest with Electrodes - I, Model H:Leg Rest with Electrodes - II, Model I:Shirt with Electrodes) are cutaneous electrodes.
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K Number
K202638Device Name
Pain Therapy Device
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2021-07-15
(307 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pain Therapy Device (Model: P.T.S-III):
TENS:
- For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
- For relief of pain associated with arthritis.
- For symptomatic relief and management of chronic intractable pain
EMS:
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- To temporarily increase local blood circulation in healthy muscles.
NEMS:
- For relaxation of muscle spasm.
- Increase of blood flow circulation.
- Prevention or retardation of disuse muscle atrophy.
- Muscle re-education.
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Device Description
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K Number
K200402Device Name
DR-HO'S Electro Therapy Conductive Gel
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2020-11-25
(280 days)
Product Code
GYB
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Device Description
DR-HO'S Electro Therapy Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%, And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
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K Number
K190118Device Name
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2020-05-13
(475 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Xinbo Electronic Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.
Device Description
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