Data / Medical devices / United States / Xtreem Pulse
Xtreem Pulse: FDA-registered device maker in New York, NY, United States, 5 510(k) clearances
Xtreem Pulse is registered with the FDA (registration 3012470925) in New York, NY, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012470925
- Address
- 690 Washington St # 4B, New York, NY, United States, 10014
- Owner or operator
- XTREEM PULSE (10057865)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 5, 2018
- Registered through
- 2026
- Brand names listed
- Pure Flow, PureLift, PureLift PRO, PureLift Pro Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 2025 | K243587 | PureLift GLOW | NFO | Substantially Equivalent | Xtreem Pulse, LLC | accessdata.fda.gov |
| June 21, 2023 | K230506 | PureLift Pro Edition | NFO | Substantially Equivalent | Xtreem Pulse | accessdata.fda.gov |
| October 21, 2022 | K221443 | PureLift Pro Plus | NFO | Substantially Equivalent | Xtreem Pulse, LLC | accessdata.fda.gov |
| August 28, 2019 | K190269 | PureLift | NFO | Substantially Equivalent | Xtreem Pulse, LLC | accessdata.fda.gov |
| May 30, 2018 | K173483 | Pure Flow External Counter-Pulsation Device | DRN | Substantially Equivalent | Xtreem Pulse, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Counter-Pulsating, External
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated March 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.