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510(k) Data Aggregation
K Number
K150695Device Name
Modpod
Manufacturer
HOLLYWOG, LLC
Date Cleared
2015-08-13
(148 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
HOLLYWOG, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fracture
• Joint pain
• Discogenic pain
Device Description
The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.
The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.
Painted sheet metal and ABS plastic encasement housing electronic circuitry; software and electronics engage a gear driven motor with load sensors; slide mechanism, and patient head harness to apply cervical traction.
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K Number
K120500Device Name
THE PAIN PILOT (A.K.A PAIN PILOT)
Manufacturer
HOLLYWOG, LLC
Date Cleared
2012-08-20
(181 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HOLLYWOG, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the user's lower back.
Device Description
The device is a battery powered over the counter transcutaneous electrical nerve stimulator with a wireless remote control feature. The general purpose of the device is to apply an electrical stimulus to integral electrodes that are applied to a user's lower back to relieve pain. The device includes a current generator and permanently-affixed electrodes with user replaceable single patient use hydrogel pads (gel-pads) that may be reused for a limited number of reuses. The number of reuses of the gel-pads varv person-to-person dependent upon skin type, oils and pH levels. One side of the adhesive gel-pad adheres to the electrode, and the other the device to the healthy intact skin of the user's lower back to provide an analgesic electrical stimulus to the painful area. The user controls are located on a hand-held wireless remote control commonly referred to as a Key-fob. The user controls are simple straightforward power on/off and electrical stimulus intensity up/down.
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K Number
K120398Device Name
WITOUCH PRO
Manufacturer
HOLLYWOG, LLC
Date Cleared
2012-08-16
(190 days)
Product Code
GZJ, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HOLLYWOG, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WiTouch" Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.
Device Description
The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.
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