ELECTROCYN soma
510(k) K220286
ELECTROCYN soma is a device classified as Unclassified made by V3Bio Sdn. Bhd, cleared under FDA 510(k) K220286 on 21 Dec 2022, 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 | NumberK220286 | Date21 Dec 2022 | StatusActive |
Official records
- FDA 510(k) database K220286
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRO
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code FRO (Dressing, Wound, Drug).
- Xonrid Gel by Helsinn Healthcare SA
- DERMAGRAN WOUND DRESSING by Derma Sciences, Inc.
- HemCon GuardaCare® PRO, 2in x 2in, 8ply 1 1012 by Tricol Biomedical Inc
- Hydrocleanse Antimicrobial Skin and Wound Care Solution by Sonoma Pharmaceuticals, Inc.
- MILLIKEN SILVER WOUND DRESSINGS by Milliken Chemical
- ANTIBACTERIAL ADHESIVE BANDAGE by William Feinstein & Associates, Inc.
- Anexa Wound Flush, Sterile Water & Sterile Normal Saline by Anexa Biomedical, Inc.
- SILVER ALGINATE II WOUND DRESSING by ADVANCED MEDICAL SOLUTIONS LIMITED
- 3M TEGADERM CHG DRESSING by 3M COMPANY
- AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER by Convatec, Ltd.