510(k) · Cleared

Cleared

Slendertone Flex Bottom & Thigh Toning System, Type 511

K022855510(k) TraditionalCleared Mar 6, 2003191-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

Bio-Medical Research, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning

Cleared on Mar 6, 2003 as substantially equivalent to K010335 (Bio-Medical Research, Ltd., 2001) after a 191-day review. Its family tree reaches back 1 generation to 2001. 53 later devices descend from it.

Decided: Mar 6, 2003
Review: 191 days
Class: Class II
Product code: NGX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010335 (2001). 53 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
This deviceK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
Descendant · cites it directly · 52 of its ownK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
Descendant · 2 generations on · 26 of its ownK092142 Sport-Elec Body Control System BSSport-Elec · 2010
Descendant · 2 generations on · 25 of its ownK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
Descendant · cites it directly · 23 of its ownK091865 Sport-Elec Body Control SystemSport-Elec · 2009
Descendant · 2 generations on · 22 of its ownK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2007high 6 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 53 · See all

K070142Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Bio-Medical Research Corp. · 2007 · cites it directly52descendants
K092142Sport-Elec Body Control System BSSport-Elec · 2010 · 2 generations on26descendants
K072553System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007 · 2 generations on25descendants
K091865Sport-Elec Body Control SystemSport-Elec · 2009 · cites it directly23descendants
K092476Sport-Elec Body Control System, Model 4MSport-Elec · 2010 · 2 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010335	Slendertone Flex, Model, 512	Bio-Medical Research, Ltd.	2001	—
0 (this device)	K022855	Slendertone Flex Bottom & Thigh Toning System, Type 511	Bio-Medical Research, Ltd.	2003	—
+1	K070142	Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts…	Bio-Medical Research Corp.	2007	—
+2	K092142	Sport-Elec Body Control System BS	Sport-Elec	2010	—
+2	K072553	System-Arms, Model 390,E60	Bio-Medical Research, Ltd.	2007	—
+1	K091865	Sport-Elec Body Control System	Sport-Elec	2009	—
+2	K092476	Sport-Elec Body Control System, Model 4M	Sport-Elec	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	3	0
2008	1	0
2009	4	0
2010	3	0
2011	1	0
2012	1	0
2013	3	0
2014	1	0
2015	6	0
2016	3	0
2018	4	0
2019	3	0
2020	1	0
2021	6	0
2022	2	0
2023	1	0
2024	5	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K022855, 2001–2026Source: 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
*	K010335	Slendertone Flex, Model, 512	Bio-Medical Research, Ltd.	2001	—

Also cleared against K010335: 8 other devices →

What descends from it? (53)

See all 53

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070142	Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20	Bio-Medical Research Corp.	2007	52
K091865	Sport-Elec Body Control System	Sport-Elec	2009	23

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?

Its one ancestor has no recall.
Of its descendants, K070142 (Bio-Medical Research Corp., 2007) has gone furthest, with 52 descendants of its own.
8 other devices also cite its predicate K010335.

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.

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?

Strengthening,toning and firming of the bottom and thigh reglon

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022855 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022855: Slendertone Flex Bottom & Thigh Toning System, Type 511.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022855

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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