The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Bx-1000 Isomatic.
| Device ID | K820080 |
| 510k Number | K820080 |
| Device Name: | BX-1000 ISOMATIC |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BLOOMEX INTERNATIONAL, INC. NY |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-12 |
| Decision Date | 1982-07-01 |