# Xtreem Pulse, LLC

- Location (FDA's records): New York, NY
- FDA decisions: 6 (2018–2026): 6 510(k) clearances
- Names in FDA's records: Xtreem Pulse, LLC (5); Xtreem Pulse (1)
- Product codes: NFO (5), DRN (1)
- 510(k) review time since 2016: median 112 days, against 139 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)
- Led Technologies, Inc.: 1 (https://510kreport.com/company/led-technologies)
- Carol Cole Company Dba Nuface: 1 (https://510kreport.com/company/carol-cole-company-dba-nuface)
- Carol Cole Company: 1 (https://510kreport.com/company/carol-cole)
- Stage 2 Innovations: 1 (https://510kreport.com/company/stage-2-innovations)

## Firms that cite its devices most
- Shenzhen Siken 3D Technology Development Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-siken-3d-technology-development)
- Geske Beauty Tech GmbH: 1 (https://510kreport.com/company/geske-beauty-tech)
- Vamed Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/vamed-medical-instrument)
- Shenzhen Kaiyan Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical-equipment)
- Guangdong Newdermo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangdong-newdermo-biotech)
- Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/touchbeauty-beauty-health-shenzhen)

## Its most-cited devices
- K221443: PureLift Pro Plus (2022), cited by 6
- K230506: PureLift Pro Edition (2023), cited by 1
- K243587: PureLift GLOW (2025), cited by 1
- K190269: PureLift (2019), cited by 1
- K173483: Pure Flow External Counter-Pulsation Device (2018), cited by 1

## Recent decisions
- K262861: PureLift Pro Max (Sep 11, 2026)
- K243587: PureLift GLOW (Mar 6, 2025)
- K230506: PureLift Pro Edition (Jun 21, 2023)
- K221443: PureLift Pro Plus (Oct 21, 2022)
- K190269: PureLift (Aug 28, 2019)
- K173483: Pure Flow External Counter-Pulsation Device (May 30, 2018)

Source page: https://510kreport.com/company/xtreem-pulse