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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Nuga Medical Co., Ltd
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
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?
Applicant Name (Manufacturer) :
NUGA MEDICAL CO., LTD
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
K111329Device Name
NM-7000
Manufacturer
NUGA MEDICAL CO., LTD
Date Cleared
2011-09-06
(118 days)
Product Code
JFB, ILY, ISA
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
NUGA MEDICAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the NM-7000 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- Temporary relief of minor muscle and joint pain, and stiffness -
- The temporary relief of minor joint pain associated with arthritis -
- The temporary increase in local circulation where applied -
- Relaxation of muscles -
Device Description
The NM-7000 Personal Heating Therapeutic Device is an electric multifunctional physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage. It includes ceramics which emit far infrared radiation and is for temporary easing of muscle pains, joint aches, and stiffening.
This device is made up of the main mat, auxiliary mat, frame, 5ball, 9ball external light projector, Leg holding heater as well as a regulator that can regulate and control the function of the device. Inside the main mat, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed. A motor that can operate the heating ceramics top down, the main pcb, and a temperature sensor that can control the temperature are attached to the internal heating ceramics.
When massaging the cervical vertebra to lumbar, place the upper body over the main mat, and place the leg on the auxiliary mat which has the heating function. Also, when massaging the leg, it can be used the other way. The internal light projector moves and massages the area where the muscle has cramped and is aching and at the same time, provides thermotherapy that can relax the muscle.
The 5ball or 9ball Tourmanium projector was designed in a way it can manually provide thermotherapy and stimulation for the aching area and can easily be selected according to the aching area.
The leg holding heater can additionally provide thermotherapy for the knee or calf and was designed in a way it can be attached and fixed after wrapping the frame with a integrated Velcro band.
The main mat and auxiliary mat are both separate module types and are installed above the frame. They should be connected with the Velcro of each mat area, attached, and fixed.
The connection cable that can link the main mat with the auxiliary mat provides power for the heater from the main mat to the auxiliary mat.
The electronic components of each module such as the traction motor are loaded above the lower plywood of each module.
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