NIO+ Adult
FDA 510(k) clearance K211968 · decided 2021-07-22
Clearance details
- K-number
- K211968
- Device name
- NIO+ Adult
- Applicant
- Waismed, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-24
- Decision date
- 2021-07-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rosh Ha'Ayin, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 1050009 recall (Z-2119-2025) | Waismed Ltd. | 2025-07-17 |