RF1400 Active Compression Wrap
510(k) K162481
RF1400 Active Compression Wrap is a medical device (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Recovery Force, LLC, cleared under FDA 510(k) K162481 on 16 Feb 2017, 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 | NumberK162481 | Date16 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K162481
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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