ELITE

Stimulator, Muscle, Powered

BLOOMEX INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Elite.

Pre-market Notification Details

• Device ID: K810246
• 510k Number: K810246
• Device Name: ELITE
• Classification: Stimulator, Muscle, Powered
• Applicant: BLOOMEX INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: IPF
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-01-29
• Decision Date: 1981-03-16