Data / Medical devices / United States / Forcemech International LLC.
Forcemech International LLC.: FDA-registered device maker in Katy, TX, United States, 5 510(k) clearances
Forcemech International LLC. is registered with the FDA (registration 3013934051) in Katy, TX, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013934051
- Address
- 4219 Clay Commerce Dr Ste 103, Katy, TX, United States, 77449
- Owner or operator
- Forcemech International LLC. (10055638)
- Roles
- Repackager or relabeler
- First device listed
- August 29, 2017
- Registered through
- 2026
- Brand names listed
- Forcemech, Forcemech Liberty, PathMate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | 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 |
|---|---|---|---|---|---|---|
| November 27, 2024 | K242308 | Power wheelchair | ITI | Substantially Equivalent | Zhejiang Zhonglei Medical Technology Co. , Ltd. | accessdata.fda.gov |
| August 29, 2024 | K240105 | Navigator (FMNVG15); Navigator XL (FMNVX06) | ITI | Substantially Equivalent | Forcemech International, LLC | accessdata.fda.gov |
| July 19, 2023 | K231472 | Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) | INI | Substantially Equivalent | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | accessdata.fda.gov |
| August 9, 2017 | K170787 | Powered Wheelchair DYW30A(D09) | ITI | Substantially Equivalent | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | accessdata.fda.gov |
| March 22, 2007 | K070501 | RUIKE 3421 POWERED WHEELCHAIR | ITI | Substantially Equivalent | Shanghai Ruike Sports Goods Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 27, 2024. 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.