510(k) · Cleared
ClearedSystem-Arms, Model 390,E60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Dec 14, 2007 as substantially equivalent to K070142 (Bio-Medical Research Corp., 2007) after a 95-day review. Its family tree reaches back 3 generations to 2001. 25 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 95 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010335 (2001). 4 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 2 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 1 generation backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- This deviceK072553 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
- Descendant · 3 generations on · 12 of its ownK182106 BTL 799-2TBTL Industries, Inc. · 2018
- Descendant · 4 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · 5 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K091865Sport-Elec Body Control SystemSport-Elec · 2009 · cites it directly23descendants
- K092476Sport-Elec Body Control System, Model 4MSport-Elec · 2010 · 2 generations on22descendants
- K182106BTL 799-2TBTL Industries, Inc. · 2018 · 3 generations on12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 4 generations on11descendants
- K200382BTL-703-2Btl · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +3 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +4 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +5 | K200382 | BTL-703-2 | Btl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Summary page 1…evice Name: System-Abs, Type 390, Model E£0 and X10 Manufacturer: Bio-Medical Research Ltd 5 10(k) No: K070142, March 2007 4. Description of Device System-Arms, Type 390, Model E60 is a two-channel, battery powered muscle stimulation syste… | 2007 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091865 (Sport-Elec, 2009) has gone furthest, with 23 descendants of its own.
- 5 other devices also cite its predicate K070142.
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. 2007, 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?
Toning of the triceps muscles of the upper arms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072553: System-Arms, Model 390,E60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072553
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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