StarFormer
StarFormer is a non-invasive magnetic stimulation system intended for adjunctive therapy under medical supervision. The FDA filing describes stimulation of neuromuscular tissue for bulk…
StarFormer is a non-invasive magnetic stimulation system intended for adjunctive therapy under medical supervision. The FDA filing describes stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
The listed uses include muscle-spasm relaxation, muscle re-education and maintaining or increasing range of motion. Separate indications concern abdominal tone and strength and strengthening or toning the buttocks and thighs. This description is specific to StarFormer, not TightWave.
Listed Item
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.
Indicated Muscle Uses
StarFormer is identified as a magnetic stimulator for adjunctive therapy under medical supervision. Its listed uses include muscle-spasm relaxation, muscle re-education and strengthening or toning of the buttocks and thighs.
Who Else Makes It
Concentrated in Guangdong (25), Beijing (3), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
Showing 12 of 33. All 33 manufacturers in China registered for Stimulator, Muscle, Powered
Record
| Listed by | Fotona D.O.O., Slovenia |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Establishment | Manufacturer |
| 510(k) | K221274 |
| Record published | 2024-07-30 |
| Record revised | 2025-06-13 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 20 to 90 % RH; Handling environment temperature 10 to 25 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 700 to 1060 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M008-3T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QB1 Nmes System | Motive Health, Inc. | 69 |
| MyndMove | Myndtec Inc | 44 |
| GEM-Stim | Gemore Technology Co., Ltd. | 38 |
| Chattanooga | DJO, LLC | 27 |
| ReGrasp | Rehabtronics, Inc. | 19 |
| Stimulation System | Edan Instruments, Inc. | 16 |
| e-vive II Nmes System | Motive Health, Inc. | 16 |
| L300 Go System | Bioness Medical, Inc. | 11 |
| Motive Knee System | Motive Health, Inc. | 9 |
| Ness H200® Wireless Hand Rehabilitation System | Bioness Medical, Inc. | 9 |
| BodyMed | Boxout, LLC | 8 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 7 |
Showing 12 of 204. All products under Stimulator, Muscle, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221274 | 2023-09-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.