Medical Device Manufacturer · US , Mchenry , IL

Bloomex International, Inc. - FDA 510(k) Cleared Devices

16 submissions · 14 cleared · Since 1979

16

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bloomex International, Inc. Physical Medicine ✕

15 devices

1-15 of 15

Cleared Aug 14, 1995

Physical Medicine · 489d

Cleared Aug 14, 1995

Physical Medicine · 489d

Cleared Jun 25, 1984

Physical Medicine · 26d

Cleared May 30, 1984

ELECTRONIC MUSCLE EXERCISE EQUIPMENT

Physical Medicine · 30d

Cleared Nov 25, 1983

Physical Medicine · 84d

Cleared Oct 13, 1982

BX-500 ELECTRONIC MUSCLE EXERCISER

Physical Medicine · 75d

Cleared Jul 01, 1982

BX-1000 ISOMATIC

Physical Medicine · 170d

Cleared Jul 01, 1982

ELECTRONIC MUSCLE EXERCISER

Physical Medicine · 72d

Cleared Mar 08, 1982

BX-400 JESSE JIMBODY

Physical Medicine · 94d

Cleared Mar 08, 1982

Physical Medicine · 89d

Cleared Nov 23, 1981

MODEL P-8 PROFESSIONAL

Physical Medicine · 214d

Cleared Jun 12, 1981

Physical Medicine · 63d

Cleared Mar 16, 1981

Physical Medicine · 46d

Cleared Mar 10, 1981

Physical Medicine · 40d

Cleared May 07, 1979

Physical Medicine · 104d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026