The following data is part of a premarket notification filed by Max Mobility, Llc with the FDA for Smartdrive Wheelchair Power Assist.
| Device ID | K151199 |
| 510k Number | K151199 |
| Device Name: | SmartDrive Wheelchair Power Assist |
| Classification | Wheelchair, Powered |
| Applicant | MAX MOBILITY, LLC 5425 Crossings Blvd. Antioch, TN 37013 |
| Contact | Ben Hemkens |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-05-05 |
| Decision Date | 2015-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861896000310 | K151199 | 000 |
| 00861896000303 | K151199 | 000 |