ManaCold Compression System
by Manamed LLC
510(k) K260944
ManaCold Compression System is a medical device (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Manamed LLC, cleared under FDA 510(k) K260944 on 12 Aug 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260944 | Date12 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K260944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IRP
- FDA applicant
- Manamed, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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