Gymmax Technology Shenzhen Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 5 products catalogued, 1 clearance.
Gymmax Technology Shenzhen Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Powered Laser Surgical Instrument and 6 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | GYMMAX TECHNOLOGY SHENZHEN CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007689716 |
| FEI number | 3007689716 |
| DUNS | 526849191 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 4F&5F, 4th Bldg, Heping Complex (4th Bldg. Huimingsheng Technology Park) |
| Postal code | 518103 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | 2024 | 47 | |
| Lamp, Infrared, Therapeutic Heating | Class 2 | 2019 | 235 | |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | 2011 | 67 | |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | 2019 | 59 | |
| Powered Laser Surgical Instrument | Class 2 | 2011 | 92 | |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | 2020 | 22 | |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Versatone, Versatone Gen II, Flextone, | 2020 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Versatone, Versatone Gen II, Flextone, | 2020 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| versatone | NUH | 2 |
| versatone-xt | NUH | 2 |
| versatone – xt | GXY | 2 |
| versatone | GXY | 2 |
| Gymmax | NUH | 1 |
Clearances
1 clearance names Gymmax Technology Shenzhen Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240108 | 2024-06-10 | GXY | Traditional | This company |
| K232439 | 2024-03-21 | NUH | Traditional | Gymmax Technology Shenzen Co., Ltd. |
| K192201 | 2020-06-12 | NUH | Traditional | Gymmax Technology Shenzen Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Fitness gym equipment, Commercial strength machines, Cardio machines, Crossfit rigs, Home gyms |
|---|---|
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.