The following data is part of a premarket notification filed by Radius Intl., Inc. with the FDA for Radius Manual Whwwlchairs (cobra, Viper, Swing, Olympia, And Mobil Models).
Device ID | K951560 |
510k Number | K951560 |
Device Name: | RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) |
Classification | Wheelchair, Mechanical |
Applicant | RADIUS INTL., INC. WATER GARDENS PLACE, SUITE 320 100 EAST 15TH STREET Ft. Worth, TX 76102 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer RADIUS INTL., INC. WATER GARDENS PLACE, SUITE 320 100 EAST 15TH STREET Ft. Worth, TX 76102 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-05 |
Decision Date | 1995-04-17 |