DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

BIOWAVE CORPORATION

The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Deepwave Percutaneous Neuromodulation Pain Therapy System.

Pre-market Notification Details

• Device ID: K061166
• 510k Number: K061166
• Device Name: DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
• Classification: Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
• Applicant: BIOWAVE CORPORATION 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Mary Mcnamara-cullinane
• Correspondent: Mary Mcnamara-cullinane; BIOWAVE CORPORATION 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: NHI
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-27
• Decision Date: 2006-08-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859911006065	K061166	000
10859911006024	K061166	000
20859911006007	K061166	000