The following data is part of a premarket notification filed by Medical Rehab Products, Llc with the FDA for Athena 190.
Device ID | K173360 |
510k Number | K173360 |
Device Name: | Athena 190 |
Classification | Wheelchair, Mechanical |
Applicant | Medical Rehab Products, LLC PO BOX 1182 Montreat, NC 28757 |
Contact | Brad Evans |
Correspondent | Brad Evans Medical Rehab Products, LLC PO BOX 1182 Montreat, NC 28757 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-26 |
Decision Date | 2018-05-17 |