ampcarellc.comAMPCARE ESP THERAPY SYSTEM
AMPCARE, LLC
AMPCARE, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008273892 | 3008273892 | AMPCARE, LLC | 1 | N | 2026-01-01 | 1120 South Fwy Suite 111 Fort Worth TX US 76104 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00867786000200 | E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only. | 1-682-561-2444 | info@ampcarellc.com |
| 00867786000217 | E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only. | 1-682-561-2444 | info@ampcarellc.com |
| 00867786000231 | AMPCARE Restorative Posture Device - Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use. | 1-682-561-2444 | info@ampcarellc.com |
| 10867786000214 | E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only. | 1-682-561-2444 | info@ampcarellc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 151989 | 2023086744 | K131222 | AMPCARE ESP THERAPY SYSTEM | IPF | 2013-10-31 |
| 151989 | 1962893016 | K121483 | REUSABLE CUTANEOUS ELECTRODE | GXY | 2012-10-15 |
| 151989 | 1917400948 |
Product Codes Associated With Registrations#
PMN#
REUSABLE CUTANEOUS ELECTRODE
AMPCARE, LLC
GUDID#
E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only.
2017-03-15
E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only.
2017-03-15
AMPCARE Restorative Posture Device - Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.
2020-06-26
E Series - Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only.
2017-03-15