510(k) clearance
MeCare Alpha (MCA2019)
- 510(k) number
- K260426
- Applicant
- IVT Medical, Ltd.
- Decision date
- Oct 8, 2026
- Date received
- Feb 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OMP
- Device type
- Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II
- Regulation
- 21 CFR 878.4780
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Ra'Anana, IL