510(k) · Cleared
ClearedNoodle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pourang Bral, Dds, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 9, 2022 as substantially equivalent to K130802 (Shenzhen Dongdixin Technology Co., Ltd., 2013) after a 131-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Jul 9, 2022
- Review
- 131 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130802 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- This deviceK220573 NoodlePourang Bral, Dds, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K220573 | Noodle | Pourang Bral, Dds, LLC | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Summary page 4…stimulator for pain relief. Once it is activated, it operates for 25 seconds and shuts off automatically. Identification of the predicate device Predicate Device K130802 Device name OTC Electrical Stimulator LT3060 Common or usual name Transcutaneous El… | 2013 |
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?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K130802.
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. 2022, 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?
Noodle is intended to reduce the pain of hypodermic injections into the upper extremities (arms), lower extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age. The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers. Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such…
Read the full statement (120 words)
Noodle is intended to reduce the pain of hypodermic injections into the upper extremities (arms), lower extremities (leg),
buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.
The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by
professional healthcare providers.
Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such as
the upper and lower extremities (arms and legs), buttocks, abdomen, and deltoid and is not intended to be used on smaller
body parts such as the hands, feet, head (including ears, nose and around the eyes), the neck, and the abdominal area in
pregnant women.
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/K220573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220573: Noodle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220573
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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