FDA UDI
In Commercial Distribution
🇺🇸 United States
SANO
DI: 06973511890061
·
Model: SHE-MSP002
·
Beijing Sano Lasers S&T Development Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SANO
- Primary DI
- 06973511890061
- Version / Model
- SHE-MSP002
- Company Name
- Beijing Sano Lasers S&T Development Co., Ltd.
- Labeler DUNS
- 414243850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- 52319bef-cc62-4752-9bdd-2307c01f4080
Device Description
The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58762 | Deep-tissue electromagnetic stimulation system, professional | An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); 3) help facilitate soft and hard tissue wound/injury healing; and/or 4) reduce subcutaneous fat layers by muscle stimulation. It includes an electrically-powered control unit and application pads/flat coils intended to emit EM radiation to the treatment site. It is not intended to apply an electric current directly to the body nor produce therapeutic deep heat. The system is intended to be used in a clinical setting only. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973511890061 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230024 | 000 |