The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Semi-recumbent Cycles.
| Device ID | K935216 |
| 510k Number | K935216 |
| Device Name: | SEMI-RECUMBENT CYCLES |
| Classification | Exerciser, Powered |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Product Code | BXB |
| Subsequent Product Code | DRT |
| Subsequent Product Code | IKK |
| Subsequent Product Code | ISD |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1994-09-16 |