Cleared Traditional

K241365 - Pixie Pulse (SM9068)

K241365 is an FDA 510(k) clearance for Pixie Pulse (SM9068), manufactured by Pixie Cup, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241365 · Pixie Cup, LLC · Neurology device
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Aug 2024
Decision
90d
Days
Class 2
Risk

K241365 is an FDA 510(k) clearance for the Pixie Pulse (SM9068). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Pixie Cup, LLC (Walnut Shade, US). The FDA issued a Cleared decision on August 12, 2024 after a review of 90 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 Pixie Cup, LLC devices

FDA 510(k) Submission Details - K241365

510(k) Number K241365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2024
Decision Date August 12, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K241365.
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
K242567 · Changsha Anxiang Medical Technology Co., Ltd. · Nov 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · Well-Life Healthcare Limited · Oct 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · Shenzhen Minghuangda Electronics Co., Ltd. · Sep 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · Shenzhen Yicai Health Technology Co., Ltd. · Jul 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K233067 · Chongqing Rob Linka Science and Technology Co., Ltd. · Jul 2024
TENS&EMS units (SM9109A, SM9109B)
K241509 · Plexus Yoga, LLC Dba Chirp · Jun 2024