UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES

Stimulator, Electrical, Non-implantable, For Incontinence

LABORIE MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Laborie Medical Technologies with the FDA for Urostym Biofeedback And Stimulation Device And Accessories.

Pre-market Notification Details

• Device ID: K070331
• 510k Number: K070331
• Device Name: UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
• Classification: Stimulator, Electrical, Non-implantable, For Incontinence
• Applicant: LABORIE MEDICAL TECHNOLOGIES 400 AVENUE D SUITE 10 Williston, VT 05495
• Contact: Barbara Mornet
• Correspondent: Barbara Mornet; LABORIE MEDICAL TECHNOLOGIES 400 AVENUE D SUITE 10 Williston, VT 05495
• Product Code: KPI
• CFR Regulation Number: 876.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-05
• Decision Date: 2007-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00627825014557	K070331	000
00627825014540	K070331	000