Cleared Traditional

K233054 - Well-Life Pain Relief (Menstrual Plus) ...

Also marketed or referenced as:
TENS/EMS WITH Menstrual Relief Stimulator Well-Life Pain Relief Stimulator Menstrual Plus Stimulator

K233054 is the FDA 510(k) clearance for Well-Life Pain Relief (Menstrual Plus) ... by Well-Life Healthcare Limited. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K233054 · Well-Life Healthcare Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
389d
Days
Class 2
Risk

K233054 is an FDA 510(k) clearance for the Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (New Taipei City, TW). The FDA issued a Cleared decision on October 18, 2024 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Well-Life Healthcare Limited devices

Submission Details

510(k) Number K233054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date October 18, 2024
Days to Decision 389 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
241d slower than avg
Panel avg: 148d · This submission: 389d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K233054.
Nooro Body & Foot Stimulator (SM9141, SM9142)
K243334 · Xf Agencija Limited · Nov 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
K242332 · Shenzhen Kentro Medical Electronics Co., Ltd. · Nov 2024
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
K242567 · Changsha Anxiang Medical Technology Co., Ltd. · Nov 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · Shenzhen Minghuangda Electronics Co., Ltd. · Sep 2024
Pixie Pulse (SM9068)
K241365 · Pixie Cup, LLC · Aug 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · Shenzhen Yicai Health Technology Co., Ltd. · Jul 2024