510(k) · Cleared
ClearedAM-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Feb 16, 2017 as substantially equivalent to K131291 (Johari Digital Healthcare, Ltd., 2013) after a 98-day review. Its family tree reaches back 2 generations to 2007. 23 later devices descend from it.
- Decided
- Feb 16, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062439 (2007). 23 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 1 generation backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- This deviceK163165 AM-100BTL Industries, Inc. · 2017
- Descendant · cites it directly · 21 of its ownK180813 BTL 799-2BTL Industries, Inc. · 2018
- Descendant · 2 generations on · 12 of its ownK182106 BTL 799-2TBTL Industries, Inc. · 2018
- Descendant · 3 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · 2 generations on · 3 of its ownK182963 emFieldProZimmer Medizinsysteme GmbH · 2019
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K180813BTL 799-2BTL Industries, Inc. · 2018 · cites it directly21descendants
- K182106BTL 799-2TBTL Industries, Inc. · 2018 · 2 generations on12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 3 generations on11descendants
- K200382BTL-703-2Btl · 2021 · 4 generations on4descendants
- K182963emFieldProZimmer Medizinsysteme GmbH · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −1 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| 0 (this device) | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| +1 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| +2 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +3 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +4 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +2 | K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K131291 | Torc BodySummary page 4…tially equivalent to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number: Torc Body (K131291) 510(k) Summary - Page 1 of 6 The HPM-6000 device was used as a reference… | 2013 |
| † | K160992 | HPM-6000 | 2016 |
What descends from it? (23)
See all 232 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 10 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180813 (BTL Industries, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K131291.
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. 2017, 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?
AM-100 is indicated to be used for:
Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
Strengthening, Toning and Firming of buttocks and thighs.
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/K163165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163165: AM-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163165
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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