510(k) · Cleared
ClearedNuEra Tight Family, EMS Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bios S.R.L. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Dec 31, 2020 as substantially equivalent to K190456 (BTL Industries, Inc., 2019) after a 238-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Dec 31, 2020
- Review
- 238 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010335 (2001). 19 ancestors in all, the oldest K952089 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 7 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 6 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 5 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 4 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 3 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 2 generations backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- 1 generation backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- This deviceK201239 NuEra Tight Family, EMS ModelBios S.R.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −7 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −6 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −5 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −4 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −3 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −2 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| −1 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| 0 (this device) | K201239 | NuEra Tight Family, EMS Model | Bios S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190456 | BTL 799-2LSummary page 4…ss II Product Codes NGX Regulation Names Stimulator, muscle, powered, for muscle conditioning Predicate Device for EMS Treatments K190456 NGX, 890.5850 Powered Muscle Stimulator (BTL 799-2L) BTL Industries, Inc. Device Description NuE… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 19 ancestors has a recall.
- 4 other devices also cite its predicate K190456.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
The NuEra Tight Family, EMS Model, is intended for:
- improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- strengthening, toning and firming of buttocks, thighs and calves;
- improvement of muscle tone and firmness, for strengthening muscles in arms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201239: NuEra Tight Family, EMS Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201239
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026