The following data is part of a premarket notification filed by Naico Corp. with the FDA for Naico Wheel Chairs.
Device ID | K923291 |
510k Number | K923291 |
Device Name: | NAICO WHEEL CHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | NAICO CORP. 5868 W. 71ST ST. Indianapolis, IN 46278 |
Contact | Tona L Hwang |
Correspondent | Tona L Hwang NAICO CORP. 5868 W. 71ST ST. Indianapolis, IN 46278 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-06 |
Decision Date | 1992-08-06 |