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510(k) Data Aggregation
K Number
K081835Device Name
ACTICARE IC AND TSE
Manufacturer
BIOINDUCTION LIMITED
Date Cleared
2009-03-19
(265 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIOINDUCTION LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:
the symptomatic relief of chronic intractable pain, and
as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
As a Neuromuscular Electrostimulation (NMES) device for:
the relaxation of muscle spasms,
prevention or retardation of disuse atrophy,
increasing local blood circulation,
muscle re-education,
immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
and
to maintain or increase the range of motion.
Device Description
Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.
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