Plexus

Sleeve, Limb, Compressible

Alleva Medical (D.G.) Ltd

The following data is part of a premarket notification filed by Alleva Medical (d.g.) Ltd with the FDA for Plexus.

Pre-market Notification Details

• Device ID: K191107
• 510k Number: K191107
• Device Name: Plexus
• Classification: Sleeve, Limb, Compressible
• Applicant: Alleva Medical (D.G.) Ltd Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan Street Hong Kong, HK
• Contact: Max Choi
• Correspondent: Max Choi; Alleva Medical (D.G.) Ltd Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan Street Hong Kong, HK
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-26
• Decision Date: 2019-08-27