Cleared Traditional

Wireless TENS/EMS, Bruno, Aela (K220997) - FDA 510(k) Clearance

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

K220997 · Zmi Elecronics , Ltd. · Neurology device
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Sep 2022
Decision
150d
Days
Class 2
Risk

K220997 is an FDA 510(k) clearance for the Wireless TENS/EMS, Bruno, Aela. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Zmi Elecronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on September 1, 2022 after a review of 150 days - an extended review cycle.

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 Zmi Elecronics , Ltd. devices

Submission Details

510(k) Number K220997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date September 01, 2022
Days to Decision 150 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
2d slower than avg
Panel avg: 148d · This submission: 150d
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 K220997.
Everyway Analog OTC TENS
K222488 · Everyway Medical Instruments Co.,Ltd · Nov 2022
Electronic Pulse Stimulator
K221992 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · Shenzhen Future Electronic Co., Ltd. · Sep 2022
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