Data / Medical devices / United States / Helavo Corporation
Helavo Corporation: FDA-registered device maker in Miami, FL, United States, 3 510(k) clearances
Helavo Corporation is registered with the FDA (registration 3022159079) in Miami, FL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022159079
- Address
- 444 Brickell Avenue Suite 700, Miami, FL, United States, 33131
- Owner or operator
- Helavo Corporation (10084712)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- February 13, 2024
- Registered through
- 2026
- Brand names listed
- Helavo Electric Mobility Scooter H3080, helavo Electric Wheelchair Dual Battery H2010, helavo Electric Wheelchair Magnesium H2320
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 9, 2026 | K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | INI | Substantially Equivalent | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | accessdata.fda.gov |
| November 18, 2024 | K242471 | Power Wheelchair (W5538) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| September 22, 2023 | K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | ITI | Substantially Equivalent | Yurob Rehabilitation Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Walker, Mechanical
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
Updated January 9, 2026. 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.