510(k) · Cleared
ClearedTorc Body
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johari Digital Healthcare, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jun 14, 2013 as substantially equivalent to K062439 (Johari Digital Healthcare, Ltd., 2007) after a 39-day review. Its family tree reaches back 1 generation to 2007. 35 later devices descend from it.
- Decided
- Jun 14, 2013
- Review
- 39 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062439 (2007). 35 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- This deviceK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- Descendant · cites it directly · 23 of its ownK163165 AM-100BTL Industries, Inc. · 2017
- Descendant · 2 generations on · 21 of its ownK180813 BTL 799-2BTL Industries, Inc. · 2018
- 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 · cites it directly · 8 of its ownK192039 Torc BodyJohari Digital Healthcare Limited · 2020
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K163165AM-100BTL Industries, Inc. · 2017 · cites it directly23descendants
- K180813BTL 799-2BTL Industries, Inc. · 2018 · 2 generations on21descendants
- K182106BTL 799-2TBTL Industries, Inc. · 2018 · 3 generations on12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 4 generations on11descendants
- K192039Torc BodyJohari Digital Healthcare Limited · 2020 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| 0 (this device) | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| +1 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| +2 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| +3 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +4 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +1 | K192039 | Torc Body | Johari Digital Healthcare Limited | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 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 |
|---|---|---|---|
| * | K062439 | Powertone, Model PT-11Summary page 2…RE LTD. Electronic Hardware Technology Park G-582, 584 E.P.1.P., Boranada, Jodhpur 342008 : 8040537 : Not Known : POWERTONE, MODEL PT-11 : Powered Muscle Stimulator : K062439 : JOHARI DIGITAL HEALTHCARE LTD. : 8040537 ' 5.2 Special 510(K) ) Section 5 - 510(K) Summary Description of th… | 2007 |
What descends from it? (35)
See all 354 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?
- Its one ancestor has no recall.
- Of its descendants, K163165 (BTL Industries, Inc., 2017) has gone furthest, with 23 descendants of its own.
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. 2013, 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?
TORC BODY is indicated to be used for:
* Improvement of abdominal tone, for strengthening of the abdominal muscles, for
development of firmer abdomen.
e Strengthening, Toning and Firming of buttocks & 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/K131291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131291: Torc Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131291
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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