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510(k) Data Aggregation
K Number
K014273Device Name
ACUSTIM
Manufacturer
S.H.P. INTL. PTY., LTD.
Date Cleared
2002-06-12
(167 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
S.H.P. INTL. PTY., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the ACUSTIM is for use as an ELECTRO-ACUPUNCTURE DEVICE. It can be used by a Physician administering to his patients, or by a patient. It is a prescription device and should be used under continued medical supervision. It does not have curative value but stimulates appropriate auricular acupuncture points. It cannot be used transcerebrally, in the carotid sinus area or during pregnancy.
Device Description
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting wires to two electrodes which make contact with the skin of the outer ear of the patient. Switching the unit on generates low level electrical pulses the strength of which are controlled by the treatment strength control button.
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K Number
K954334Device Name
ACUPLUS
Manufacturer
S.H.P. INTL. PTY., LTD.
Date Cleared
1996-01-22
(126 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
S.H.P. INTL. PTY., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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