510(k) clearance
Aerloom
- 510(k) number
- K254217
- Applicant
- Evolym, LLC
- Decision date
- Aug 31, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JOW
- Device type
- Sleeve, Limb, Compressible
- Device class
- Class II
- Regulation
- 21 CFR 870.5800
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Wilmington, DE, US