Address:601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block,Shenzhen Guangdong,CN
Device Description : Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators ( Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : Electrodes with silver conductive are conductive garments knitted from a continu Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : Electrodes with silver conductive are conductive garments knitted from a continu Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : Electrodes with silver conductive are conductive garments knitted from a continu Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : Electrodes with silver conductive are conductive garments knitted from a continu Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : Electrodes with silver conductive are conductive garments knitted from a continu Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : The proposed Electrodes with snap / Electrodes with pigtail are non-sterile lami The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : The proposed Electrodes with snap / Electrodes with pigtail are non-sterile lami The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : The proposed Electrodes with snap / Electrodes with pigtail are non-sterile lami The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No
Device Description : The proposed Electrodes with snap / Electrodes with pigtail are non-sterile lami The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Device Class : 2
Duns Number: 544436531
Premarket Exempt : No
Prescription Use : No