510(k) · Cleared
ClearedIntelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Osto Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Oct 10, 2019 as substantially equivalent to K131291 (Johari Digital Healthcare, Ltd., 2013) and 1 other predicate after a 430-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 10, 2019
- Review
- 430 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940301 (1994). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations backK011880 Compex SportCompex S.A. · 2002
- 4 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 3 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 2 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 1 generation backK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- This deviceK182136 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302…Shenzhen Osto Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −5 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −4 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −3 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −2 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −1 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| 0 (this device) | K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | Shenzhen Osto Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K131291 | Torc BodySummary page 4…e: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2 3. Predicate Device Information Predicate Device 1: 510(K) Number: K131291 Company Name: Johari Digital HealthCare Ltd. Trade/Device Name: Torc Body Common Name: Powered Muscle Stimulator Product Code: NG… | 2013 |
| * | K133929 | Health Expert Elctronic StimulatorSummary page 4…evice Name: Torc Body Common Name: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2 Predicate Device 2: 510(K) Number: K133929 Company Name: Shenzhen OSTO Technology Co., Ltd. Trade Device Name: Health Expert Electronic Stimulator Common Name: Electronic S… | 2014 |
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 25 years and passes through 7 companies; a new generation was cleared every 4.9 years on median.
- None of the 13 ancestors has a recall.
- 3 other devices also cite its predicate K131291.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
Intelligent Wireless Fitness Apparatus 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 as stated in the FDA summary.
https://510kreport.com/device/K182136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182136: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182136
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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