# NEWA Kit 1.5, pink

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/newa-kit-nd_prd00426-00>
- Manufacturer: [Endymed Medical Ltd](https://devicerts.com/manufacturers/endymed-medical-ltd) (Israel)
- Device class: Class II (US FDA)
- FDA product code: PAY
- GMDN: Home-use radio-frequency skin contouring unit (66988)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 07290014660830 · listed 2018-09-30 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA De Novo · United States · DEN150005 · decision 2015-12-18 · decision DENG · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: NEWA Kit [FDA GUDID (AccessGUDID)]
- Generic name: Home-use radio-frequency skin contouring unit [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 1.5 [FDA GUDID (AccessGUDID)]; pink [FDA GUDID (AccessGUDID)]; ND\_PRD00426-00 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07290014660830 [FDA GUDID (AccessGUDID)]
- De Novo Number: DEN150005 [FDA GUDID (AccessGUDID)]
- FDA product code: PAY [FDA GUDID (AccessGUDID)]
- GMDN term: Home-use radio-frequency skin contouring unit (66988) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4420 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: NEWA Kit 1.5, pink, Endymed Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/newa-kit-nd\_prd00426-00 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/newa-kit-nd_prd00426-00.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/newa-kit-nd\_prd00426-00
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.