ELITE

Stimulator, Muscle, Powered

BIOTONE INTERNATIONAL, INC.

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

Pre-market Notification Details

• Device ID: K812538
• 510k Number: K812538
• Device Name: ELITE
• Classification: Stimulator, Muscle, Powered
• Applicant: BIOTONE INTERNATIONAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: IPF
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-09-03
• Decision Date: 1981-12-01