The following data is part of a premarket notification filed by Max Mobility, Llc with the FDA for Smartdrive Wheelchair Power-assist.
| Device ID | K113621 |
| 510k Number | K113621 |
| Device Name: | SMARTDRIVE WHEELCHAIR POWER-ASSIST |
| Classification | Wheelchair, Powered |
| Applicant | MAX MOBILITY, LLC 5425 MOUNT VIEW PARKWAY Antioch, TN 37013 |
| Contact | William M Richter |
| Correspondent | William M Richter MAX MOBILITY, LLC 5425 MOUNT VIEW PARKWAY Antioch, TN 37013 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-08 |
| Decision Date | 2012-07-06 |