Heat Pain Pro
by Omron Healthcare, Inc. 2 variants
510(k) K160115
Heat Pain Pro is a Class II device made by Omron Healthcare, Inc., cleared under FDA 510(k) K160115 on 3 Jun 2016, 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 | NumberK160115 | Date3 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K160115
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- Withdrawn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 K160115
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 | |||
|---|---|---|---|---|
| Omron Gel Refills for PM311 PMGEL | PMGEL / PMGEL | 00073796637521 | — | On the market |
| Omron Heat Pain Pro PM311 | PM311 / PM311 | 00073796633110 | — | On the market |
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