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510(k) Data Aggregation

    K Number
    K200636
    Device Name
    AXUS ES-5 Electro-Acupuncture Device
    Manufacturer
    Lhasa OMS, INC.
    Date Cleared
    2021-02-03

    (330 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lhasa OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.
    Device Description
    The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through microalligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
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    K Number
    K062003
    Device Name
    NEURO WAVE 6
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2007-09-19

    (429 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
    Device Description
    The device consists of a battery powered portable instrument with 6 channel outputs. Weight- 2.6 kg. Color- Grey Pulse Shape- Asymmetrical, Biphasic Triangular Wave Pulse Rate- 1-100 Hz Pulse Width- Impedance Value: 500 ohms, 1000 ohms, 2000 ohms, 5000 ohms, 10000 ohms Pulse Width: 280 uS, 240 US, 220 US, 220 uS, 220 uS Output- 80 volts maximum (under 500 ohm test load) Stimulation time- stimulation time is adjusted by the timer up to 60 minutes. Device Controls- Clearly indicated are the ON/OFF (Power switch), Frequency Adjuster, Timer, and Output Intensity Knobs. Power- 6 1.5 volt C batteries
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    K Number
    K060508
    Device Name
    POINTER PLUS
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2006-06-19

    (112 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
    Device Description
    Not Found
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    K Number
    K060517
    Device Name
    POINTER EXCEL
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2006-06-19

    (112 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
    Device Description
    Not Found
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    K Number
    K061080
    Device Name
    IR PRO 250
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2006-06-14

    (57 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IR Pro 250 is intended for use in the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may help muscle spasms, minor sprains and strains, and minor back pain.
    Device Description
    The IR Pro 250 lamp can be used for topical heating of the body. It is designed to emit light between 700 to 50,000 nanometers in wavelength. The lamp uses 120 volts AC power at 250 watts. It is mounted on a swivel stand with 5 casters. An automatic timer controls exposure time.
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    K Number
    K050989
    Device Name
    AWQ-104
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2006-04-06

    (352 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
    Device Description
    The device consists of a battery powered instrument with four channel outputs. A hand held probe allows treatment at individual sites. Output polarity, frequency, intensity, and voltage are controlled by four independent channels. Each channel drives a pair of self adhesive electrodes. A grounding pole electrically grounds the device when using the hand held probe.
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    K Number
    K051020
    Device Name
    ES-160
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2006-02-24

    (308 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms. The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.
    Device Description
    The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.
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    K Number
    K050435
    Device Name
    E-STIM II
    Manufacturer
    LHASA OMS, INC.
    Date Cleared
    2005-09-06

    (196 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LHASA OMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
    Device Description
    The device consists of a battery powered portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.
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