PlasmaWave

Sleeve, Limb, Compressible

ManaMed, Inc.

The following data is part of a premarket notification filed by Manamed, Inc. with the FDA for Plasmawave.

Pre-market Notification Details

• Device ID: K211253
• 510k Number: K211253
• Device Name: PlasmaWave
• Classification: Sleeve, Limb, Compressible
• Applicant: ManaMed, Inc. 5240 W. Charleston Blvd. Las Vegas, NV 89146
• Contact: Trevor Theriot
• Correspondent: Bill Quanqin Dai; JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-26
• Decision Date: 2021-05-26