510(k) · Cleared
ClearedRevitive IX (OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actegy, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Mar 23, 2015 as substantially equivalent to K133965 (Shenzhen Dongdixin Technology Co., Ltd., 2014) and 2 other predicates after a 136-day review. Its family tree reaches back 5 generations to 1994. 17 later devices descend from it.
- Decided
- Mar 23, 2015
- Review
- 136 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K940301 (1994). 22 ancestors in all, the oldest K872976 (1987). 17 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 1 generation backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- This deviceK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
- Descendant · 2 generations on · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · 3 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · cites it directly11descendants
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021 · 2 generations on5descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · 2 generations on4descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 3 generations on2descendants
- K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| 0 (this device) | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +1 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +2 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 | — |
| +2 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +3 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| +1 | K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K133965 | Otc Ems StimulatorSummary page 4…stimulator for muscle conditioning, 21 C.F.R. § 890.5850, product code NGX/NUH Predicate Devices OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager – PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354)… | 2014 |
| * | K122744 | Prospera Otc Tens Electronic Pulse MassagerSummary page 4…uct code NGX/NUH Predicate Devices OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager – PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354) Device Description The Revitive IX (OTC) consists of foot pa… | 2013 |
| * | K123354 | Revitive IXSummary page 4…ator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager – PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354) Device Description The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical st… | 2013 |
What descends from it? (17)
See all 174 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 21 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K151834 (Bemer Int AG, 2017) has gone furthest, with 11 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. 2015, 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?
To temporarily increase local blood circulation in healthy leg muscles.
To stimulate healthy muscles in order to improve and facilitate muscle performance.
For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143207: Revitive IX (OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143207
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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