The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Bx-400s.
| Device ID | K942195 |
| 510k Number | K942195 |
| Device Name: | BX-400S |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BLOOMEX INTERNATIONAL, INC. 295 MOLNAR DR. Elmwood Park, NJ 07407 -3211 |
| Contact | Benjamin Laroux |
| Correspondent | Benjamin Laroux BLOOMEX INTERNATIONAL, INC. 295 MOLNAR DR. Elmwood Park, NJ 07407 -3211 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-12 |
| Decision Date | 1995-08-14 |