The following data is part of a premarket notification filed by Huestis Machine Corp. with the FDA for Huestis Flexi-board.
| Device ID | K904005 |
| 510k Number | K904005 |
| Device Name: | HUESTIS FLEXI-BOARD |
| Classification | System, Therapeutic, X-ray |
| Applicant | HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Contact | Terry Chwalk |
| Correspondent | Terry Chwalk HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-11-29 |