Avail
510(k) K172079
Avail is a Class II device made by Omron Healthcare, Inc., cleared under FDA 510(k) K172079 on 19 Oct 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 | NumberK172079 | Date19 Oct 2017 | StatusActive |
Official records
- FDA 510(k) database K172079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NUH
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K172079
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Avail Wireless Pad PMWPAD-L | PMWPAD-L / PMWPAD-L | 00073796276140 | — | On the market |
| Avail Wireless Pad PMWPAD-M | PMWPAD-M / PMWPAD-M | 00073796346140 | — | On the market |
| Omron Avail Wireless T.E.N.S. PM601 | PM601 / PM601 | 00073796636012 | — | No longer on the market |
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