Noodle

Stimulator, Nerve, Transcutaneous, Over-the-counter

Pourang Bral, DDS, LLC

The following data is part of a premarket notification filed by Pourang Bral, Dds, Llc with the FDA for Noodle.

Pre-market Notification Details

• Device ID: K220573
• 510k Number: K220573
• Device Name: Noodle
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: Pourang Bral, DDS, LLC 155 Albion Street Passaic, NJ 07055
• Contact: Pourang Bral
• Correspondent: Pourang Bral; Pourang Bral, DDS, LLC 155 Albion Street Passaic, NJ 07055
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-28
• Decision Date: 2022-07-09