Data / Medical devices / United States / Max Mobility, LLC
Max Mobility, LLC: FDA-registered device maker in Lebanon, TN, United States, 2 510(k) clearances
Max Mobility, LLC is registered with the FDA (registration 3008370857) in Lebanon, TN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2015. 3 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008370857
- Address
- 300 Duke DR, Lebanon, TN, United States, 37090
- Owner or operator
- Max Mobility, LLC (10032721)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 5, 2012
- Registered through
- 2026
- Brand names listed
- SmartDrive, SmartDrive MX2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 30, 2015 | K151199 | SmartDrive Wheelchair Power Assist | ITI | Substantially Equivalent | Max Mobility, LLC | accessdata.fda.gov |
| July 6, 2012 | K113621 | SMARTDRIVE WHEELCHAIR POWER-ASSIST | ITI | Substantially Equivalent | Max Mobility, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2025 | 97356 | Class I | Ongoing | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. | accessdata.fda.gov |
| December 20, 2024 | 96086 | Class I | Ongoing | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries. | accessdata.fda.gov |
| May 10, 2023 | 92250 | Class II | Ongoing | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicate | When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2025. 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.