QuantumStar, StarFormer

Basic Information

• Brand Name: QuantumStar, StarFormer
• Primary DI: 03830054238138
• 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: 2025-06-12
• Public Version: 1
• Public Version Date: 2025-06-20
• Public Version Status: New
• Public Device Record Key: 5582e6ce-9491-46bb-9154-89b8802bfcad

Device Description

It is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions.

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	03830054238138	GS1

Premarket Submissions

Submission Number	Supplement Number
K234061	000
K241785	000

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