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510(k) Data Aggregation

    K Number
    K233046
    Device Name
    Electrical Neuromuscular Stimulator, Cure Trio
    Manufacturer
    Oriental Inspiration Limited
    Date Cleared
    2024-04-19

    (207 days)

    Product Code
    GZJ, GZI, IPF, NGX, NUH, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oriental Inspiration Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
    Device Description
    The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation. a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
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    K Number
    K213133
    Device Name
    Keffort (MC-100, MC-100A)
    Manufacturer
    Oriental Inspiration Limited
    Date Cleared
    2022-04-13

    (198 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oriental Inspiration Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence for female patients and to maintain urinary continence for female patients.
    Device Description
    Not Found
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    K Number
    K212285
    Device Name
    Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
    Manufacturer
    Oriental Inspiration Limited
    Date Cleared
    2021-12-22

    (154 days)

    Product Code
    NUH, NGX, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oriental Inspiration Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 1)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) and lower extremities (leg) due to strain from exercise or normal household work activities. 2) It is also intended to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: 1) The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
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    K Number
    K170269
    Device Name
    Hee HR Mini
    Manufacturer
    Oriental Inspiration Limited
    Date Cleared
    2017-05-03

    (96 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oriental Inspiration Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The HEE HR Mini devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The HR Mini devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the HR Mini devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse. The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.
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    K Number
    K170260
    Device Name
    BC-001+ Acne Purifier
    Manufacturer
    Oriental Inspiration Limited
    Date Cleared
    2017-04-25

    (88 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oriental Inspiration Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.
    Device Description
    This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.
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