The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for M-flex 5000 C3pmd.
| Device ID | K931736 |
| 510k Number | K931736 |
| Device Name: | M-FLEX 5000 C3PMD |
| Classification | Exerciser, Powered |
| Applicant | MEDICAL SYSTEMS CORP. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Cheryl A Boyce |
| Correspondent | Cheryl A Boyce MEDICAL SYSTEMS CORP. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-07 |
| Decision Date | 1994-01-27 |