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510(k) Data Aggregation
K Number
K242940Device Name
Xrecovery (XR-001)
Manufacturer
SHENZHEN XINRUN ELECTRIC APPLIANCES CO LTD
Date Cleared
2024-11-14
(50 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xrecovery is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Device Description
The Xrecovery is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.
The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The device is intended to be used with Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. 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 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
K240986Device Name
Cold Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2024-05-01
(21 days)
Product Code
IRP, ILO
Regulation Number
890.5650Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
Device Description
The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.
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K Number
K223541Device Name
Cold/Hot Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2023-10-27
(336 days)
Product Code
IRP, ILO, JOW
Regulation Number
890.5650Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cold/Hot Compression combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
ColdHot Compression is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Device Description
The subject device is a prescriptive device, which combines cold/hot therapy and air compression. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
The subject device comes with the thermal-therapy wraps and the DVT wraps. The thermal-therapy wrap is nylon fabric on one side and velvet cloth on the other side; the DVT wrap is velvet on both sides. To avoid any potential adverse skin reactions such as redness, irritation, and cold/hot injury, the sock/clothing should be worn by the patient prior to use.
The subject device includes a main device and an optional DVT device, and has a limited shelf life of 3 years, based on the charge retention characteristics of the device's battery.
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K Number
K213294Device Name
Dermal Cooling System
Manufacturer
R2 Technologies, Inc.
Date Cleared
2022-11-10
(405 days)
Product Code
QPZ, GED, ILO
Regulation Number
878.4340Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling. inflammation, and hematoma from minor surgical procedures.
The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
Device Description
The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.
The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
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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?
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Matched: '890.5720'
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
K183702Device Name
Polar Care Wave
Manufacturer
Breg Inc.
Date Cleared
2019-03-01
(60 days)
Product Code
IRP, ILO
Regulation Number
890.5650Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Device Description
The Polar Care Wave system is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently. The device contains three key parts: A cold-compression pad with connector, 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 device is intended to be used with Breg Cold-Compression pads only, which are designed for specific application sites. 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
K132057Device Name
DYNATRON PELTIER THERMOSTIM PROBE
Manufacturer
DYNATRONICS CORP.
Date Cleared
2014-01-24
(205 days)
Product Code
GXY, DYN, ILO
Regulation Number
882.1320Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.
Device Description
The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.
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K Number
K120835Device Name
DYNATRON THERMOSTIM PROBE-DONE
Manufacturer
DYNATRONICS CORPORATION
Date Cleared
2012-08-20
(153 days)
Product Code
GXY, DYN, ILO
Regulation Number
882.1320Why did this record match?
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Matched: '890.5720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin
Device Description
The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.
The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.
There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).
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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?
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Matched: '890.5720'
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?
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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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