510(k) K151199 ยท ITI Wheelchair, Powered
SmartDrive Wheelchair Power Assist
| Applicant | Max Mobility, LLC, Antioch TN, US |
| Decision | Substantially Equivalent, Jul 30, 2015 |
| Received | May 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | None listed |
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | None listed |
| Sep 12, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component. Open, Classified |
ITI | None listed |
| Feb 11, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. Open, Classified |
ITI | None listed |
| Feb 11, 2025 | Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. Open, Classified |
ITI | None listed |
| Jun 26, 2023 | Permobil 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 w Open, Classified |
ITI | None listed |
| Jun 26, 2023 | Permobil PushTracker E3 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 w Open, Classified |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.