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510(k) Data Aggregation
K Number
K200636Device Name
AXUS ES-5 Electro-Acupuncture Device
Manufacturer
Lhasa OMS, INC.
Date Cleared
2021-02-03
(330 days)
Product Code
BWK
Regulation Number
N/AWhy 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
K062003Device Name
NEURO WAVE 6
Manufacturer
LHASA OMS, INC.
Date Cleared
2007-09-19
(429 days)
Product Code
GZJ
Regulation Number
882.5890Why 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
K060508Device Name
POINTER PLUS
Manufacturer
LHASA OMS, INC.
Date Cleared
2006-06-19
(112 days)
Product Code
GZJ
Regulation Number
882.5890Why 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
K060517Device Name
POINTER EXCEL
Manufacturer
LHASA OMS, INC.
Date Cleared
2006-06-19
(112 days)
Product Code
GZJ
Regulation Number
882.5890Why 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
K061080Device Name
IR PRO 250
Manufacturer
LHASA OMS, INC.
Date Cleared
2006-06-14
(57 days)
Product Code
ILY
Regulation Number
890.5500Why 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
K050989Device Name
AWQ-104
Manufacturer
LHASA OMS, INC.
Date Cleared
2006-04-06
(352 days)
Product Code
GZJ
Regulation Number
882.5890Why 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
K051020Device Name
ES-160
Manufacturer
LHASA OMS, INC.
Date Cleared
2006-02-24
(308 days)
Product Code
GZJ
Regulation Number
882.5890Why 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
K050435Device Name
E-STIM II
Manufacturer
LHASA OMS, INC.
Date Cleared
2005-09-06
(196 days)
Product Code
GZJ
Regulation Number
882.5890Why 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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