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 |