sedatelec.comMINISCAV
Sedation Systems LLC
SEDAT
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007143859 | 3007143859 | Sedation Systems LLC | 1 | N | 2026-01-01 | 150 Pinellas Bayway South Suites 207, 208 Tierra Verde FL US 33715 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03760262490625 | BAT02 Glass rods - The BAT02 is designed to massage reflex points or zones in the auricle. | +330472663322 | contact@sedatelec.com |
| 03760262490670 | EASYO 1 - Multi Pressure Feeler - The pressure feelers are basic tools for auriculotherapy. | +330472663322 | contact@sedatelec.com |
| 03760262492902 | PAL130 Pressure feeler 130g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure. | +330472663322 | contact@sedatelec.com |
| 03760262492926 | PAL400 Pressure feeler 400g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure. | +330472663322 | contact@sedatelec.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 92313 | 1655666572 | K160950 | MINISCAV | CBN | 2017-05-05 |
| 92313 | 1692108943 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CBN | 1 | 2017-05-05 |
PMN#
PREMIO 10 MOXA
SEDATELEC
SEDAT FLAMINGO
SEDAT
SEDAT MYSHELL LITE
SEDAT
ASP TITANIUM
SEDATELEC
DOLPHIN INFLATION DEVICE
SEDAT S.A.
MYSHELL
SEDAT S.A.
DN ACUPUNTURE NEEDLES
SEDATELEC
SEDATELEC ASP ACUPUNCTURE NEEDLES
SEDATELEC
GUDID#
PREMIO 10 MOXA - The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following:• A handpiece with a Power Supply (110-240V~ /50-60Hz)• A tip concentrator• An user manual• A cover of arrangementThe PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
2016-09-22
PAL650 Pressure feeler 650g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure.
2024-04-25
PAL400 Pressure feeler 400g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure.
2024-04-25
PAL250 Pressure feeler 250g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure.
2024-04-25
PAL130 Pressure feeler 130g - The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure.
2024-04-25
EASYO 1 - Multi Pressure Feeler - The pressure feelers are basic tools for auriculotherapy.
2024-04-25
BAT02 Glass rods - The BAT02 is designed to massage reflex points or zones in the auricle.
2024-04-25
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2023-01-12
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2016-09-22
Premio 40 - Light - The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.
2021-07-27
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2016-09-22
ASP - The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
2016-09-22