FITNESS

Exerciser, Non-measuring

FITNESS EQUIPMENT CO., INC.

The following data is part of a premarket notification filed by Fitness Equipment Co., Inc. with the FDA for Fitness.

Pre-market Notification Details

• Device ID: K833249
• 510k Number: K833249
• Device Name: FITNESS
• Classification: Exerciser, Non-measuring
• Applicant: FITNESS EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ION
• CFR Regulation Number: 890.5370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-09-23
• Decision Date: 1983-11-07