Cleared Traditional

NuEra Tight Family, EMS Model (K201239) - FDA 510(k) Clearance

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

K201239 · Bios S.R.L. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
238d
Days
Class 2
Risk

K201239 is an FDA 510(k) clearance for the NuEra Tight Family, EMS Model. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Bios S.R.L. (Vimodrone, IT). The FDA issued a Cleared decision on December 31, 2020 after a review of 238 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Bios S.R.L. devices

Submission Details

510(k) Number K201239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2020
Decision Date December 31, 2020
Days to Decision 238 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 115d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 93
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K201239.
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174 · Bemer Int AG · Feb 2021
Gymform Total ABS
K202653 · Well Brain International , Ltd. · Jan 2021
BTL-703-2
K200382 · Btl · Jan 2021
TENS & PMS
K201354 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2020
Compex Sport Elite 3.0
K201653 · Djo, LLC · Nov 2020
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
K201845 · Guangzhou Longest Science & Technology Co., Ltd. · Oct 2020