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510(k) Data Aggregation
K Number
K213097Device Name
Armory Motion
Manufacturer
Pain Management Technologies, Inc.
Date Cleared
2022-06-10
(259 days)
Product Code
ILO, IRP
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
Pain Management Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.
Device Description
Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.
The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.
The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.
The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.
The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.
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K Number
K120054Device Name
ULTIMA NEO
Manufacturer
PAIN MANAGEMENT TECHNOLOGIES
Date Cleared
2012-06-05
(151 days)
Product Code
GZJ, IPF, LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PAIN MANAGEMENT TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:
- Relaxation of muscle spasm; .
- Increasing local blood circulation and muscle re-education; ' .
- Prevention or retardation of disuse atrophy; .
- Prevention of venous thrombosis of the calf muscles immediately . after surgery;
- Maintaining or increasing range of motion. .
MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:
Symptomatic relief of chronic intractable pain. .
Device Description
A portable TENS/EMS/MIC/IF combo device for pain relief or muscle re-education.
Features:
- Innovative design
- · Large LCD display
- · Dual output isolated channels
- · One rechargeable lithium battery
- · Adjustable frequency, pulse width, and timing parameters
- 18 different modes
- · Timer option
- · Doctor lock/unlock facility
- · Open circuit detectors
- Non-volatile
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K Number
K083494Device Name
ULTIMA FIVE
Manufacturer
PAIN MANAGEMENT TECHNOLOGIES
Date Cleared
2009-01-06
(42 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PAIN MANAGEMENT TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultima Five™ external, non-invasive, non-narcotic, electrotherapy device is indicated for use as an adjunctive therapy in providing symptomatic pain relief for chronic, acute, or post-operative pain.
Device Description
The Ultima Five consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
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K Number
K073386Device Name
JOINT STIM, MODEL 1000
Manufacturer
PAIN MANAGEMENT TECHNOLOGIES
Date Cleared
2008-07-30
(240 days)
Product Code
NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PAIN MANAGEMENT TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.
The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000 is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
Device Description
The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
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K Number
K030375Device Name
SOFT-TOUCH TENS ELECTRODE
Manufacturer
PAIN MANAGEMENT TECHNOLOGIES
Date Cleared
2003-05-05
(90 days)
Product Code
GXY, 84G
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
PAIN MANAGEMENT TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMT Soft-Touch™ external TENS Electrodes are indicated for use with transcutaneous electrical stimulation devices as a non-sterile, disposable device for single patient use only. The PMT electrodes provide the conductive interface between the TENS generator and the patient's skin.
The PMT TENS electrode Soft-Touch™ are designed for, and to be used with marketed and FDA approved TENS stimulators.
Device Description
The PMT Soft-Touch™ electrodes are high quality carbon electrodes.
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K Number
K011411Device Name
SELF-ADHESIVE ELECTRODES
Manufacturer
PAIN MANAGEMENT TECHNOLOGIES
Date Cleared
2001-06-13
(36 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
PAIN MANAGEMENT TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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