Revitive IX
by Actegy, Ltd.
510(k) K123354
Revitive IX is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K123354 on 28 Jun 2013, 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 | NumberK123354 | Date28 Jun 2013 | StatusActive |
Official records
- FDA 510(k) database K123354
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- FDA applicant
- Actegy , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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