Bloomex International, Inc.
Mchenry, IL, US
Bloomex International, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Bloomex International, Inc. between 1979 and 1995. The busiest year on record is 1982, with 5. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 4 |
| 1982 | 5 |
| 1983 | 1 |
| 1984 | 2 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943185 | BX-200 SC | IPF | Substantially Equivalent for Some Indications | |
| K942195 | BX-400S | IPF | Substantially Equivalent for Some Indications | |
| K842142 | BX-400 | IPF | Substantially Equivalent | |
| K841779 | ELECTRONIC MUSCLE EXERCISE EQUIPMENT | IPF | Substantially Equivalent | |
| K832976 | BX-600 EMS | IPF | Substantially Equivalent | |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | IPF | Substantially Equivalent | |
| K821110 | ELECTRONIC MUSCLE EXERCISER | IPF | Substantially Equivalent | |
| K820080 | BX-1000 ISOMATIC | IPF | Substantially Equivalent | |
| K813443 | BX-400 SPORT | IPF | Substantially Equivalent | |
| K813410 | BX-400 JESSE JIMBODY | IPF | Substantially Equivalent | |
| K811114 | MODEL P-8 PROFESSIONAL | Substantially Equivalent | ||
| K810975 | MINITONE | IPF | Substantially Equivalent | |
| K810246 | ELITE | IPF | Substantially Equivalent | |
| K810247 | MBI-4 | IPF | Substantially Equivalent | |
| K802304 | SOLAR TONE | LEJ | Substantially Equivalent | |
| K790120 | SLENDERTONE | IPF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain