StarFormer
Basic Information
- Brand Name
- StarFormer
- Primary DI
- 03830054237728
- Version / Model
- M008-3T
- Company Name
- FOTONA d.o.o.
- Labeler DUNS
- 644720625
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 2
- Public Version Date
- 2025-06-13
- Public Version Status
- Update
- Public Device Record Key
- 360ac37a-5793-4d38-80b4-3ed3b59f94e0
Device Description
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. With handheld applicators - Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. o Relaxation of muscle spasm, o Prevention or retardation of disuse atrophy, o Increasing local blood circulation, o Muscle re-education, o Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, o Maintaining or increasing range of motion. With Chair Seat Applicator - Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
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
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology, Urology | 876.5320 | 2 |
| QPL | Electromagnetic Stimulator, Pain Relief | Neurology | 882.5890 | 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 | 03830054237728 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal