Data / Medical devices / China / Remax Medi-Tech(shenzhen) Corporation
Remax Medi-Tech(shenzhen) Corporation: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Remax Medi-Tech(shenzhen) Corporation is registered with the FDA (registration 3012234230) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated October 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012234230
- Address
- Room 303 of Factory Building, No. 32, Huiming Yi Road Guihua Community, Guanlan Street, Longhua District, Shenzhen Guangdong, China, 518110
- Owner or operator
- Remax Medi-tech(Shenzhen) Corporation (10051040)
- Roles
- Manufacturer
- First device listed
- January 27, 2016
- Registered through
- 2026
- Brand names listed
- iRestore Hair Growth System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 13, 2022 | K222081 | ID-510 iRestore Elite | OAP | Substantially Equivalent | Freedom Laser Therapy, Inc. | accessdata.fda.gov |
| December 22, 2021 | K213094 | ID-500 iRestore Hair Growth System | OAP | Substantially Equivalent | Freedom Laser Therapy, Inc. | accessdata.fda.gov |
| May 17, 2019 | K183417 | iRestore Professional 282 | OAP | Substantially Equivalent | Freedom Laser Therapy, Inc. | accessdata.fda.gov |
| January 6, 2016 | K151662 | iRestore | OAP | Substantially Equivalent | Freedom Laser Therapy, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 13, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.