HYDROTRACK

Exerciser, Powered

FERNO ILLE

The following data is part of a premarket notification filed by Ferno Ille with the FDA for Hydrotrack.

Pre-market Notification Details

• Device ID: K935509
• 510k Number: K935509
• Device Name: HYDROTRACK
• Classification: Exerciser, Powered
• Applicant: FERNO ILLE 70 WEIL WAY Wilmington, OH 45177
• Contact: Renee Walz
• Correspondent: Renee Walz; FERNO ILLE 70 WEIL WAY Wilmington, OH 45177
• Product Code: BXB
• CFR Regulation Number: 890.5380 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-15
• Decision Date: 1994-10-03