FDA UDI
In Commercial Distribution
🇺🇸 United States
STIMFIT
DI: 07640174840007
·
Model: 1.03
·
Valmed SA
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- STIMFIT
- Primary DI
- 07640174840007
- Version / Model
- 1.03
- Company Name
- Valmed SA
- Labeler DUNS
- 484275094
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-28
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 33586904-3c8e-4361-84ef-894d2c4f1729
Device Description
Electrical Muscle Stimulator for muscle conditioning.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 07640174840007 | GS1 | ||||
| Package | 07640174840021 | GS1 | box | 1 | In Commercial Distribution | |
| Package | 07640174840014 | GS1 | box | 1 | In Commercial Distribution | |
| Package | 07640174840069 | GS1 | Master carton | 20 | In Commercial Distribution | |
| Package | 07640174840052 | GS1 | Master carton | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 612-248-2331
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031611 | 000 |