Data / Medical devices / South Korea / Maxstar Industrial Co Ltd
Maxstar Industrial Co Ltd: FDA-registered device maker in Gimpo Gyeonggi, South Korea, 5 510(k) clearances
Maxstar Industrial Co Ltd is registered with the FDA (registration 3010890287) in Gimpo Gyeonggi, South Korea. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010890287
- Address
- 152-12 Hwanggeum-ro 23beon-gil Yangchon-eup, Gimpo Gyeonggi, South Korea, 415843
- Owner or operator
- Maxstar Industrial Co., Ltd. (10046491)
- Roles
- Manufacturer
- First device listed
- March 28, 2014
- Registered through
- 2026
- Brand names listed
- AIR RELAX MODEL AR-1 & MODEL AR-2, AIR RELAX MODEL UAM-8100, UAM-8100N, AIR RELAX PRO MODEL AR-4, Air Relax Plus Model AR-3, HAMMERZ, Model: HM-1, UAM-8100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| September 2, 2021 | K212491 | Air Relax Pro Model AR-4.0 | IRP | Substantially Equivalent | Diode Art Engineering Doing Business AS Air Relax | accessdata.fda.gov |
| May 25, 2021 | K211460 | Air Relax Plus Model AR-3.0 | IRP | Substantially Equivalent | Diode Art Engineering Doing Business AS Air Relax | accessdata.fda.gov |
| March 5, 2021 | K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | IRP | Substantially Equivalent | Maxstar Industrial Co., Ltd. | accessdata.fda.gov |
| May 30, 2019 | K173158 | Air Relax | IRP | Substantially Equivalent | Maxstar Industrial Co., Ltd. | accessdata.fda.gov |
| February 18, 2014 | K130385 | COMPRESSIBLE LIMB SLEEVE SYSTEM | IRP | Substantially Equivalent | Maxstar Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 2, 2021. 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.