The following data is part of a premarket notification filed by Max Mobility, Llc with the FDA for Hiroller Elevating Wheelchair.
Device ID | K102837 |
510k Number | K102837 |
Device Name: | HIROLLER ELEVATING WHEELCHAIR |
Classification | Wheelchair, Standup |
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 | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-29 |
Decision Date | 2010-12-23 |