The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Ranger Ii M6, Model In-888wnl.
Device ID | K002157 |
510k Number | K002157 |
Device Name: | RANGER II M6, MODEL IN-888WNL |
Classification | Wheelchair, Powered |
Applicant | INVACARE CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein INVACARE CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-17 |
Decision Date | 2000-08-25 |