The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Thigh And Foot Positioner, Suprone Plus, Model Rt-6010.
| Device ID | K050701 |
| 510k Number | K050701 |
| Device Name: | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817740020546 | K050701 | 000 |
| 00817740020539 | K050701 | 000 |
| 00817740020492 | K050701 | 000 |
| 00817740020461 | K050701 | 000 |
| 00817740020454 | K050701 | 000 |
| 00817740020447 | K050701 | 000 |
| 00817740020430 | K050701 | 000 |