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510(k) Data Aggregation
K Number
K063135Device Name
SONIC-STIM
Manufacturer
NAIMCO, INC.
Date Cleared
2007-02-05
(112 days)
Product Code
IMG, GZI, GZJ, IPF
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
NAIMCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Russian, and High Volt:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For interferential and premodulated interferential:
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
For Ultrasound:
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain Relief
- Reduction of muscle spasms
- Joint contractures
For TENS and EMS:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain condition
Device Description
Ultrasound and Muscle Stimulator. Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator. Available as 2 channel stimulator, 4 channel stimulator, ultrasound, 2 channel stimulator with ultrasound, and 4 channel stimulator with ultrasound. Units are supplied with electrodes listed in 510(K) K050469, typically 2 x 2 inch. Units are supplied with a bottle of ultrasound coupling gel listed in 510(K) K012522, or similar gels already in the market.
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K Number
K050469Device Name
EZ-STIK ELECTRODES
Manufacturer
NAIMCO, INC.
Date Cleared
2005-05-13
(79 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NAIMCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
Device Description
Electrodes, Cutaneous
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K Number
K040495Device Name
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
Manufacturer
NAIMCO, INC.
Date Cleared
2004-04-22
(56 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
NAIMCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NAImco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.
Device Description
The Naimco, Inc. Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The Naimco, Inc. Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCI) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.
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