FDA UDI
In Commercial Distribution
🇺🇸 United States
SimulCareII
DI: B495SIMULCAREII0
·
Model: SimulCareII
·
XANACARE TECHNOLOGIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SimulCareII
- Primary DI
- B495SIMULCAREII0
- Version / Model
- SimulCareII
- Company Name
- XANACARE TECHNOLOGIES
- Labeler DUNS
- 556994536
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6f363575-4610-4c7e-96ed-5e7ba42fe308
Device Description
The SimluCare II Multifunction Therapeutic Device is intended for the temporary relieve of minor muscle and joint pain, promoting the relaxation of muscle tissues, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61169 | Transcutaneous electrical stimulation probe | A non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B495SIMULCAREII0 | HIBCC |