Cleared Traditional

K231053 - Unicare (K-UNICARE-USA)

K231053 is an FDA 510(k) clearance for Unicare (K-UNICARE-USA), manufactured by Tenscare, Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 127-day FDA review.

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

FDA 510(k) Submission Details - K231053

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.

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 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