The following data is part of a premarket notification filed by Stealth Products with the FDA for Stealth Products Seating System.
Device ID | K050264 |
510k Number | K050264 |
Device Name: | STEALTH PRODUCTS SEATING SYSTEM |
Classification | Wheelchair, Powered |
Applicant | STEALTH PRODUCTS 5905 FAWN LANE Cleveland, OH 44141 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll STEALTH PRODUCTS 5905 FAWN LANE Cleveland, OH 44141 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-04 |
Decision Date | 2005-02-11 |
Summary: | summary |