K260944
- 510(k) number
- K260944
- Device name
- ManaCold Compression System
- Applicant
- Manamed, LLC TX · US
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2026-08-12
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.