FDA UDI
In Commercial Distribution
🇺🇸 United States
Verve Deluxe
DI: 06970890320547
·
Model: AS2015
·
Shenzhen As-Tec Technology Co.,Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Verve Deluxe
- Primary DI
- 06970890320547
- Version / Model
- AS2015
- Company Name
- Shenzhen As-Tec Technology Co.,Ltd.
- Labeler DUNS
- 421355284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-28
- Public Version
- 2
- Public Version Date
- 2024-12-03
- Public Version Status
- Update
- Public Device Record Key
- 010d4cdb-5caa-4c60-b77d-707df299cdef
Device Description
used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,upper extremities(arm), and lower extremities( leg), due to strain from exercise or normal household and work activities.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970890320547 | GS1 | ||||
| Package | 16970890320544 | GS1 | master carton | 24 | Not in Commercial Distribution | 2024-12-03 |
Customer Contacts
- Phone
- +8618194084892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200727 | 000 |