The following data is part of a premarket notification filed by Excel Mobility Products, Inc. with the FDA for Rangeroller.
Device ID | K915152 |
510k Number | K915152 |
Device Name: | RANGEROLLER |
Classification | Wheelchair, Powered |
Applicant | EXCEL MOBILITY PRODUCTS, INC. 636 CONSTITUTION AVE, N.E. Washington, DC 20002 |
Contact | Ragnar U Thoresen |
Correspondent | Ragnar U Thoresen EXCEL MOBILITY PRODUCTS, INC. 636 CONSTITUTION AVE, N.E. Washington, DC 20002 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-14 |
Decision Date | 1992-01-09 |