VPULSE

Sleeve, Limb, Compressible

COTHERA, LLC

The following data is part of a premarket notification filed by Cothera, Llc with the FDA for Vpulse.

Pre-market Notification Details

• Device ID: K122640
• 510k Number: K122640
• Device Name: VPULSE
• Classification: Sleeve, Limb, Compressible
• Applicant: COTHERA, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005
• Contact: Justin Eggleton
• Correspondent: Justin Eggleton; COTHERA, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-29
• Decision Date: 2013-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00672736065303	K122640	000
00672736064825	K122640	000
00672736064948	K122640	000
00672736064955	K122640	000
00672736064962	K122640	000
00672736064979	K122640	000
00672736064986	K122640	000
00672736065051	K122640	000
00672736065068	K122640	000
00672736065099	K122640	000
00672736065112	K122640	000
00672736065150	K122640	000
00672736065167	K122640	000
00672736064818	K122640	000