NomadAir PMU810
510(k) K220631
NomadAir PMU810 is a Class II device made by Neurotronics, Inc., cleared under FDA 510(k) K220631 on 15 Jul 2022, active as of 9 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 | NumberK220631 | Date15 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K220631
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWL
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1835
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K220631
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 | |||
|---|---|---|---|---|
| NomadAir PMU810 Portable Recorder | PMU810 | 00817111021189 | — | On the market |
| NomadAir PMU810 RIP Belt, Large | PMU810 | 00817111021219 | — | On the market |
| NomadAir PMU810 RIP Belt, Medium | PMU810 | 00817111021202 | — | On the market |
| NomadAir PMU810 RIP Belt, Small | PMU810 | 00817111021196 | — | On the market |
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