The following data is part of a premarket notification filed by Permobil Of America with the FDA for Permobil Maxior.
Device ID | K870224 |
510k Number | K870224 |
Device Name: | PERMOBIL MAXIOR |
Classification | Wheelchair, Powered |
Applicant | PERMOBIL OF AMERICA BOX 20 1644 MASSACHUSETTS AVENUE Lexington, MA 02173 |
Contact | Finkelstein, Md |
Correspondent | Finkelstein, Md PERMOBIL OF AMERICA BOX 20 1644 MASSACHUSETTS AVENUE Lexington, MA 02173 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-21 |
Decision Date | 1987-02-10 |