Aerloom— 510(k) K254217
Substantially EquivalentEvolym, LLC
FDA 510(k) clearance K254217 for Aerloom, Substantially Equivalent on 2026-08-31. Applicant: Evolym, LLC. Device class: 2.
Summary
Evolym's Aerloom is filed under product code JOW, compressible limb sleeves. The record gives no model numbers or description beyond the name and that code.
Class II, 21 CFR 870.5800. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Evolym filed from Wilmington, Delaware. FDA found it substantially equivalent 245 calendar days after receiving it (December 29, 2025 to August 31, 2026).
Clearance details
- Applicant
- Evolym, LLC
- Product code
- Product code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code JOW
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