FDA UDI
In Commercial Distribution
🇺🇸 United States
emFieldPro
DI: 04053815074151
·
Model: 5032
·
Zimmer MedizinSysteme GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- emFieldPro
- Primary DI
- 04053815074151
- Version / Model
- 5032
- Catalog Number
- 5032
- Company Name
- Zimmer MedizinSysteme GmbH
- Labeler DUNS
- 316111251
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 2
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 5a29aedd-0dd6-4614-ae69-83b6e584e0af
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 | 04053815074151 | GS1 |
Customer Contacts
- Phone
- (888) 935-8471
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182963 | 000 |