# K220573: Noodle

- Pathway: 510(k) (Traditional)
- Applicant: Pourang Bral, Dds, LLC
- Decided: Jul 9, 2022 after 131 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K130802 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060), Shenzhen Dongdixin Technology Co., Ltd. (2013) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K220573
Methodology: https://510kreport.com/methodology