The following data is part of a premarket notification filed by Dyna Flex, Intl. with the FDA for Romflex Rehab Equip Extremities Unit.
| Device ID | K910150 |
| 510k Number | K910150 |
| Device Name: | ROMFLEX REHAB EQUIP EXTREMITIES UNIT |
| Classification | Exerciser, Powered |
| Applicant | DYNA FLEX, INTL. 151 EAST BROAD ST. Clinton, TN 37716 |
| Contact | Harrison Beal |
| Correspondent | Harrison Beal DYNA FLEX, INTL. 151 EAST BROAD ST. Clinton, TN 37716 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-01-23 |