FDA UDI
In Commercial Distribution
🇺🇸 United States
AMPCARE Restorative Posture Device
DI: 00867786000231
·
Model: RPD
·
AMPCARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMPCARE Restorative Posture Device
- Primary DI
- 00867786000231
- Version / Model
- RPD
- Catalog Number
- 50707
- Company Name
- AMPCARE, LLC
- Labeler DUNS
- 013052325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-26
- Public Version
- 1
- Public Version Date
- 2020-07-06
- Public Version Status
- New
- Public Device Record Key
- a9264c10-9f9b-44fa-9f92-398f08dc0451
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQF | Orthosis, Cervical-Thoracic, Rigid | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41453 | Cervicothoracic spine orthosis | An externally applied orthopaedic appliance or device, also known as a cervical-thoracic orthosis (CTO), designed to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00867786000231 | GS1 |
Customer Contacts
- Phone
- 1-682-561-2444
- [email protected]