FDA UDI
In Commercial Distribution
🇺🇸 United States
VQ ORTHOCARE
DI: 00817717020142
·
Model: 55-92000-301
·
Vision Quest Industries Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VQ ORTHOCARE
- Primary DI
- 00817717020142
- Version / Model
- 55-92000-301
- Company Name
- Vision Quest Industries Incorporated
- Labeler DUNS
- 791122422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-05
- Public Version
- 6
- Public Version Date
- 2023-07-14
- Public Version Status
- Update
- Public Device Record Key
- 2e2a760c-09fc-4dc8-a6ed-0204a2feb253
Device Description
BIONICARE KNEE SYSTEM MEDIUM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58911 | Arthritis transcutaneous electrical joint stimulation system | An assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating arthritic tissue in a joint across the skin (transcutaneously); it is not intended for neurostimulation. It typically consists of an external electric current generator and electrodes (leads) that are placed on the skin with conductive patches to deliver pulsed electrical fields to the painful arthritic tissue. It is intended for routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817717020142 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030332 | 000 |