Cleared Traditional

K220573 - Noodle

K220573 is an FDA 510(k) clearance for Noodle, manufactured by Pourang Bral, Dds, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K220573 · Pourang Bral, Dds, LLC · Neurology device
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Jul 2022
Decision
131d
Days
Class 2
Risk

K220573 is an FDA 510(k) clearance for the Noodle. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Pourang Bral, Dds, LLC (Passaic, US). The FDA issued a Cleared decision on July 9, 2022 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pourang Bral, Dds, LLC devices

FDA 510(k) Submission Details - K220573

510(k) Number K220573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date July 09, 2022
Days to Decision 131 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 148d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 157
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K220573.
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K220998 · Shenzhen Kentro Medical Electronics Co., Ltd. · Aug 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · Well-Life Healthcare Limited · Aug 2022
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K221251 · Guangzhou Huakai Electronic Technology Co., Ltd. · Jul 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · Hivox Biotek, Inc. · Jun 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · Dongguan Bohuikang Technology Co.,Ltd · May 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · Hong Qiangxing (Shenzhen) Electronics Limited · May 2022