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510(k) Data Aggregation
K Number
K220573Device Name
Noodle
Manufacturer
Date Cleared
2022-07-09
(131 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Pourang Bral, DDS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Noodle is intended to reduce the pain of hypodermic injections into the upper 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.
Device Description
Noodle is a battery-operated handheld device that includes a TENS unit and a motor operated by a 9V commercial battery. The classification product code for Noodle is a Class II Device: § 882.5890 - Transcutaneous electrical nerve stimulator for pain relief. Once it is activated, it operates for 25 seconds and shuts off automatically.
Noodle consists of a TENS unit and a small motor that causes a polyurethane sponge stick to rotate and tap the skin. The combination of the TENS application and tapping on the skin for 25 seconds numbs the skin temporarily for a subsequent injection. The sponge stick is impregnated in 70% isopropanol and disinfects the injection site at the same time it taps it.
The device body has 5 pieces, the enclosure, the bottom, the battery door, and the receptacle. Noodle further includes a PCB that is controlled by a firmware. The PCB supplies TENS stimulation that is transferred to the skin by a pair of hydrogels that come in electrical contact with the skin around the injection site.
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