510(k) · Cleared
ClearedPowertone, Model PT-11
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 Jan 8, 2007 after a 140-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.
- Decided
- Jan 8, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 1 citing it directly.
- This deviceK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- Descendant · cites it directly · 35 of its ownK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- Descendant · 2 generations on · 23 of its ownK163165 AM-100BTL Industries, Inc. · 2017
- Descendant · 3 generations on · 21 of its ownK180813 BTL 799-2BTL Industries, Inc. · 2018
- Descendant · 4 generations on · 12 of its ownK182106 BTL 799-2TBTL Industries, Inc. · 2018
- Descendant · 5 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K131291Torc BodyJohari Digital Healthcare, Ltd. · 2013 · cites it directly35descendants
- K163165AM-100BTL Industries, Inc. · 2017 · 2 generations on23descendants
- K180813BTL 799-2BTL Industries, Inc. · 2018 · 3 generations on21descendants
- K182106BTL 799-2TBTL Industries, Inc. · 2018 · 4 generations on12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| +1 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| +2 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| +3 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| +4 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +5 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Slendertone Flex BT Named without a submission number | |
| * | — | Slendertone Flex Max Named without a submission number |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131291 | Torc Body | 2013 | 35 |
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?
- Of its descendants, K131291 (Johari Digital Healthcare, Ltd., 2013) has gone furthest, with 35 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. 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?
POWERTONE PT-11 is intended to be used for:
* Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen.
* Strengthening, toning and firming of buttocks & thigh
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/K062439 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062439: Powertone, Model PT-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062439
Report an extraction error
Are you the manufacturer?
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