FDA UDI
In Commercial Distribution
🇺🇸 United States
NO
DI: 06970890320622
·
Model: AS816
·
Shenzhen As-Tec Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NO
- Primary DI
- 06970890320622
- Version / Model
- AS816
- 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
- 2024-10-18
- Public Version
- 3
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- d099048f-3aa1-4c06-991f-a53cf943a9a5
- Distribution End Date
- 2029-10-18
Device Description
the foot massager with vibration and heat is provide temporary relief from stress, fatique and soreness in the feet. As an added feature, you may use the included electrode cables, belt to administer massage to other parts of the body, including the legs, arms, back, etc.
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
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35538 | Freestanding electric massager | An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970890320622 | GS1 | ||||
| Package | 16970890320629 | GS1 | master carton | 4 | Not in Commercial Distribution | 2024-08-20 |
Customer Contacts
- Phone
- +86-18194084892
- [email protected]