510(k) · Cleared

Cleared

Mini Masseuse

K110057510(k) TraditionalCleared Oct 28, 2011291-day reviewClass II21 CFR 890.5850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mj Specialty Retail · NGX Stimulator, Muscle, Powered, For Muscle Conditioning

Cleared on Oct 28, 2011 as substantially equivalent to K071666 (Bio-Medical Research Corp., 2008) after a 291-day review. Its family tree reaches back 3 generations to 1994.

Decided: Oct 28, 2011
Review: 291 days
Class: Class II
Product code: NGX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K940301 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
2 generations backK011880 Compex SportCompex S.A. · 2002
1 generation backK071666 Slendertone Enervive, Model 561Bio-Medical Research Corp. · 2008
This deviceK110057 Mini MasseuseMj Specialty Retail · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K940301	Compex 2	Biodex Medical Systems, Inc.	1994	—
−2	K011880	Compex Sport	Compex S.A.	2002	—
−1	K071666	Slendertone Enervive, Model 561	Bio-Medical Research Corp.	2008	—
0 (this device)	K110057	Mini Masseuse	Mj Specialty Retail	2011	—

FIG. 1 — Lineage of K110057, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K071666	Slendertone Enervive, Model 561 Summary page 2 ….1. Predicate/Legally Marketed Device -Model Manufacturer K Number Submitted Device SLENDERTONE BIO-MEDICAL K071666 Mini, Model EC12_01 ENERVIVE, RESEARCH MODEL 561 CORP. TOP-RANK TOP-RANK…	Bio-Medical Research Corp.	2008	—

Also cleared against K071666: 3 other devices →

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 17 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K071666.

How does its category compare?

All NGX devices

NGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NGX

15in 2025

2007high 15 (2025) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGX

93in 2025

2007high 362 (2012) · low 93 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NGX

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGX

15in 2025

2007high 21 (2016) · low 0 (2007)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?

Mini, Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini programs are designed for injured or ailing muscles and their use on such muscles is contraindicated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K110057 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110057: Mini Masseuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110057

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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