Cleared Traditional

Unicare (K-UNICARE-USA) (K231053) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231053 · Tenscare, Ltd. · Neurology device
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Aug 2023
Decision
127d
Days
Class 2
Risk

K231053 is an FDA 510(k) clearance for the Unicare (K-UNICARE-USA). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on August 18, 2023 after a review of 127 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 Tenscare, Ltd. devices

Submission Details

510(k) Number K231053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2023
Decision Date August 18, 2023
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
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 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K231053.
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
K232517 · Shenzhen Kentro Medical Electronics Co., Ltd. · Dec 2023
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K231569 · Manamed, Inc. · Nov 2023
Heating Tens, FT-615
K232675 · Hivox Biotek, Inc. · Oct 2023
Nu-beca Transcutaneous Electrical Nerve Stimulation
K223151 · Nu-Beca & Maxcellent Co. · Jul 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K230443 · Jiangxi Royall Smart Technology Co., Ltd. · May 2023
HEATING TENS/EMS, FT-810R
K223308 · Hivox Biotek, Inc. · May 2023