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Ampcare Restorative Posture Device (RPD)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50707
by Ampcare, LLC
Identity
- Trade Name
- Ampcare Restorative Posture Device (RPD) EUDAMEDAMPCARE Restorative Posture Device FDA UDI
- Generic Name
- Cervicothoracic spine orthosis FDA UDI
- Device Name
- Ampcare Restorative Posture Device (RPD) EUDAMEDRestorative 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. FDA UDI
- Model / Reference
- 50707 EUDAMEDRPD FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 50707 FDA UDI
- Primary DI / UDI-DI
- 00867786000231 EUDAMEDFDA UDI
- Basic UDI-DI
- 0867786000250707KH EUDAMED
- FDA Product Code
- IQF FDA UDI
- EMDN Code
- Y060315 CERVICOTHORACIC SPINE ORTHOSES EUDAMED
- GMDN Term
- Cervicothoracic spine orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ampcare Restorative Posture Device (RPD) by Ampcare, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0867786000250707KH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ampcare, LLC
- EUDAMED SRN
- US-MF-000038602
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED faeb319e-72f1-44fb-94ec-0a1694981044 61 fields · synced Jun 18, 2026
- FDA UDI a9264c10-9f9b-44fa-9f92-398f08dc0451 35 fields · synced May 30, 2026