PocketDoc™ Micro Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

Pensar Medical, LLC

The following data is part of a premarket notification filed by Pensar Medical, Llc with the FDA for Pocketdoc™ Micro Wound Therapy System.

Pre-market Notification Details

• Device ID: K200223
• 510k Number: K200223
• Device Name: PocketDoc™ Micro Wound Therapy System
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: Pensar Medical, LLC 684 Parkridge Avenue Norco, CA 92860
• Contact: David Buchicchio
• Correspondent: Pierre Bounaud; AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110
• Product Code: OMP
• CFR Regulation Number: 878.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-01-29
• Decision Date: 2020-10-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851978007467	K200223	000
00851978007610	K200223	000
00851978007580	K200223	000
00851978007597	K200223	000
00851978007559	K200223	000
00851978007566	K200223	000
00851978007573	K200223	000
00851978007542	K200223	000
00851978007528	K200223	000
00851978007535	K200223	000
00851978007504	K200223	000
00851978007511	K200223	000
00851978007153	K200223	000
00851978007146	K200223	000
00851978007603	K200223	000