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K Number
K241193Device Name
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
Manufacturer
Marzzan Lucas Jorge
Date Cleared
2025-01-31
(277 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
Device Description
The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.
Manual operation systems:
- . Headpiece.
- . Extension of feet.
- Drops. .
- Dorso - lumbar release/breakaway
- Lateral Flexion. ●
Electrical operating systems:
- . Horizontal elevation.
- . Flexion of the lower limb sector.
- Extension or linear movement of the lower limb sector (distraction/traction).
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K Number
K243644Device Name
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
Manufacturer
CERAGEM Co, Ltd.
Date Cleared
2025-01-08
(43 days)
Product Code
JFB, IRP
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302 is to provide muscle relaxation therapy by delivering heat and soothing massage.
Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
The Air Cell Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.
Device Description
Not Found
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K Number
K243355Device Name
Ceragem Automatic Thermal Massager (CGM-MB-1902)
Manufacturer
CERAGEM Co, Ltd.
Date Cleared
2024-11-27
(29 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1902 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Device Description
Not Found
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K Number
K240168Device Name
N7-S
Manufacturer
Nuga Medical Co., Ltd.
Date Cleared
2024-09-12
(234 days)
Product Code
JFB, IRP
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-Temporary relief of minor joint pain associated with arthritis.
-The temporary increase in local circulation where applied.
-Relaxation of muscle.
The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
Device Description
The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
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K Number
K223464Device Name
Leg and Foot Air Wave Pressure Therapy Device
Manufacturer
Zhangzhou Easepal Innovation Co Ltd.
Date Cleared
2023-03-14
(117 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate kneading and stroking of tissues by using an inflatable garment.
Device Description
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health. The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.
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K Number
K220572Device Name
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
Manufacturer
CERAGEM Co, Ltd.
Date Cleared
2022-06-17
(109 days)
Product Code
JFB, IRP
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
-Temporary relief of minor muscle and joint pain stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied
- Relaxation of muscles
The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.
Device Description
The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 4 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure cognized to the sensor, cycling airflow into and out of sleeves to compress body.
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K Number
K202937Device Name
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
Manufacturer
Ceragem Co, Ltd.
Date Cleared
2021-03-18
(169 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Device Description
The Ceragem Automatic Thermal Massager which offers two models, CGM MB-1701 & CGM MB-1702 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from up and down movement of the internal motor, and heat from the internal and external projectors.
The main components of the subject device are a main table mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main table has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and up/down and vertically along the spinal line. The main table mat has a heating pad for thermal effect.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
The only difference between the model CGM MB-1701 and the CGM MB-1702 is that the CGM MB-1701 has an air massage module for calf on the supporting mat. The supporting mat of the both models has a heating pad.
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K Number
K202113Device Name
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Manufacturer
Ceragem Co, Ltd.
Date Cleared
2021-03-02
(215 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
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Matched: '890.5880'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Device Description
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors. The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
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K Number
K153054Device Name
N5-1
Manufacturer
NUGA MEDICAL CO., LTD
Date Cleared
2016-02-05
(108 days)
Product Code
JFB, ILY, ISA
Regulation Number
890.5880Why did this record match?
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Matched: '890.5880'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
- Temporary relief of minor joint pain associated with arthritis.
- The temporary increase in local circulation where applied.
- Relaxation of muscle.
Device Description
The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:
- (1) Main assembly
- (2) 5-Ball Projector
- (3) Remote Control
- (4) Accessories
Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.
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K Number
K140592Device Name
CERAGEM AUTOMATIC THERMAL MASSAGER
Manufacturer
Ceragem International Inc.
Date Cleared
2014-12-17
(285 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Device Description
This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
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