510(k) · Cleared
ClearedSystem-Arms, Models 390, X60
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 16, 2008 as substantially equivalent to K071666 (Bio-Medical Research Corp., 2008) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 16, 2008
- Review
- 50 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010335 (2001). 8 ancestors in all, the oldest K940301 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 3 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 2 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 1 generation backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- This deviceK083164 System-Arms, Models 390, X60Bio-Medical Research, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −3 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −2 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −1 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| 0 (this device) | K083164 | System-Arms, Models 390, X60 | Bio-Medical Research, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K071666 | Slendertone Enervive, Model 561Summary page 1…System-Arms Type 390, E60 Manufacturer: Bio-Medical Research Ltd Bio-Medical Research Ltd 510(k) Nos: K071666 K072553 4. Description of Device System Arms, Type 390, Model X60 is a two-channel, batt… | 2008 |
| * | K072553 | System-Arms, Model 390,E60Summary page 1…Manufacturer: Bio-Medical Research Ltd Bio-Medical Research Ltd 510(k) Nos: K071666 K072553 4. Description of Device System Arms, Type 390, Model X60 is a two-channel, battery -powered, muscle stimulation… | 2007 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K071666.
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. 2008, 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?
System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083164: System-Arms, Models 390, X60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083164
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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