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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?
Product Code :
ILO
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
K083008Device Name
COOLSKIN
Manufacturer
ELBIO CO., LTD
Date Cleared
2009-06-10
(245 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
Device Description
COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.
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K Number
K073675Device Name
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
Manufacturer
GAYMAR INDUSTRIES, INC.
Date Cleared
2008-05-08
(132 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.
Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.
Device Description
The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points, which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point).
The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy.
The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate.
The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.
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K Number
K072152Device Name
JUNIPER CLN1 DERMAL COOLING DEVICE
Manufacturer
JUNIPER MEDICAL INC.
Date Cleared
2007-09-07
(35 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Juniper CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.
The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.
Device Description
The Juniper CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered massage.
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K Number
K070402Device Name
MODIFICATION TO POLAR CARE 500
Manufacturer
BREG, INC.
Date Cleared
2007-03-29
(45 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
- Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
- Temporary decrease in blood circulation, where applied, . reduces pain and swelling.
Device Description
Not Found
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K Number
K040317Device Name
IVC SYSTEM
Manufacturer
MARK H. FRIEDMAN
Date Cleared
2004-05-07
(88 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.
Device Description
IVC™ device
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K Number
K973023Device Name
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
Manufacturer
HOLLISTER, INC.
Date Cleared
1997-11-03
(81 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is intended to provide hot/cold therapy for body surfaces.
Device Description
The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the Foot/Ankle surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the Foot/Ankle. The proposed HOT/ICE System Foot/Ankle Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.
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K Number
K970197Device Name
HTP-1500 LOCALIZED HEAT THERAPY PUMP
Manufacturer
ADROIT MEDICAL SYSTEMS, INC.
Date Cleared
1997-09-10
(232 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.
Device Description
The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled electric water heater containing a water reservoir, an electric resistance heater, a heat exchanger, an integral electric pump and associated tubing, hoses and fittings that allow it to be connected to a separate external pad. In use, the pump circulates water from the reservoir through the heat exchanger, associated tubing, hoses and fittings into and through the external pad. The operator, using a membrane switch keypad, selects the desired water temperature as observed and confirmed on a digital display. The electronic controller selectively turns on and off the electric resistance heater to heat the heat exchanger, thereby heating the water to the desired temperature. The actual water temperature is monitored and displayed on a digital display.
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K Number
K964354Device Name
ARTOCOOL-S WATER CIRCULATING COLD PACK
Manufacturer
ORMED GMBH
Date Cleared
1997-08-29
(302 days)
Product Code
ILO, 89I
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: Localized cold therapy for post-traumatic and post-surgical medical and or surgical conditions.
Indications For Use:
1. Treatment of pain and swelling of acute periarticular processes.
2. Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia.
3. Treatment of pain and swelling postoperatively for bones, joints and soft tissue.
4. Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Device Description
The Artrocool® - S is a typical cold liquid recirculating cryotherapy device. The Artrocool® -S is an insulated ice chest-like box with a closed loop liquid recirculating pump and tubing. The tubing connects to a variety of cuffs designed to be placed on or around injured or post surgical body structures, limbs or joints. The device operates by the use of a water filled cartridge and an insulated chest. The water filled bottle is frozen solid prior to first use. When the bottle is frozen, it is placed within the insulated chamber of the Artrocool. A 4:1 mixture of water and alcohol is poured into the fluid reservoir (balancing container) until full. The pump is circulated with the connecting tubing and cuff attached. Once both are filled and all air bubbles have been purged from the system the unit is ready for service.
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K Number
K964799Device Name
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
Manufacturer
ORMED GMBH
Date Cleared
1997-08-29
(273 days)
Product Code
ILO, 891
Regulation Number
890.5720Why did this record match?
Product Code :
ILO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.
1) Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Device Description
The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROTHERM™ are shaped to better contour to different body surfaces. Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps. The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps. Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C.
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