Sozo
FDA 510(k) K190529 · ImpediMed Limited
510(k) numberK190529
Submission
- Device name
- Sozo
- Applicant
- ImpediMed Limited
Pinkenba, AU - Received
- March 4, 2019
- Decision date
- November 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJB – Adjunct Monitor, Protein Calorie Malnutrition
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
Other 510(k)s with product code QJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230531 | SOZO ProQJB · Special | ImpediMed Limited | 05/04/2023SE |
More from ImpediMed Limited
| 510(k) | Device | Decision |
|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | 08/17/2026SE |
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional | 01/28/2026SE |
| K232089 | SOZO ProDSB · Traditional | 10/17/2023SE |
| K230531 | SOZO ProQJB · Special | 05/04/2023SE |
| K230530 | SOZO ProOBH · Special | 05/04/2023SE |
| K203473 | SozoDSB · Traditional | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | 10/02/2020SE |
| K180126 | SozoOBH · Traditional | 04/16/2018SE |
| K172507 | SozoDSB · Traditional | 12/22/2017SE |
| K172122 | SozoOBH · Special | 08/11/2017SE |
Questions and answers
When was Sozo cleared by the FDA?
Sozo (K190529) received a 510(k) decision of Substantially Equivalent on November 25, 2019, 266 days after the submission was received.
What is the product code of K190529?
The FDA product code is QJB – Adjunct Monitor, Protein Calorie Malnutrition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.