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510(k) Data Aggregation
K Number
K131923Device Name
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
Manufacturer
Date Cleared
2014-07-03
(372 days)
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
TECHLINK INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indications for FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
Indications for TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
Device Description
The device NEURODYN PORTABLE TENS/FES is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC converter, with independent controls, Liquid Crystal Display. with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.
The device NEURODYN PORTABLE TENS is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC, with independent controls, Liquid Crystal Display with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.
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