ManaCold Compression System— 510(k) K260944
Substantially EquivalentManamed, LLC
FDA 510(k) clearance K260944 for ManaCold Compression System, Substantially Equivalent on 2026-08-12. Applicant: Manamed, LLC. Device class: 2.
Summary
ManaMed's ManaCold Compression System is filed under product code IRP, powered inflatable tube massagers. The record gives no model numbers.
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel. The submission was a Traditional 510(k).
ManaMed filed from Denton, Texas. FDA found it substantially equivalent 142 calendar days after receipt (March 23 to August 12, 2026).
Clearance details
- Applicant
- Manamed, LLC
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denton, TX, US
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More clearances from Manamed, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.