K234155
- 510(k) number
- K234155
- Device name
- Nimbl (model PD08-N1)
- Applicant
- Tactile Medical MN · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2024-06-21
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K234155.pdf
Official FDA record: K234155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.