Ampcare Esp Therapy System
by Ampcare, LLC
510(k) K131222
Ampcare Esp Therapy System is a Class II device made by Ampcare, LLC, cleared under FDA 510(k) K131222 on 31 Oct 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 | NumberK131222 | Date31 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K131222
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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