Insulia
6 catalogue numbers from Redwing W_1.6_US, listed by Voluntis, France, under Calculator, Drug Dose. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Voluntis, France |
|---|---|
| FDA product code | NDC |
| Device type | Calculator, Drug Dose |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| Establishment | Manufacturer |
| 510(k) | K172177 |
| Record published | 2018-08-21 |
| Record revised | 2023-11-03 (version 11) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2019-11-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Redwing W_1.6_US | In distribution | |
| Redwing A_1.6_US | In distribution | |
| Redwing I_1.6_US | In distribution | |
| Redwing 1AUS | Withdrawn | |
| Redwing 1WUS | Withdrawn | |
| REdwing 1IUS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welldoc | Welldoc | 16 |
| Healthfirst Cares Rx | Welldoc | 6 |
| Bluestar | Welldoc | 6 |
| Healthfirst Cares | Welldoc | 5 |
| Conifer Connect Diabetes | Welldoc | 5 |
| Welldoc Rx | Welldoc | 5 |
| LivingConnected Diabetes Rx | Welldoc | 5 |
| Bluestar Rx | Welldoc | 5 |
| Conifer Connect Diabetes Rx | Welldoc | 5 |
| inpen™ | Medtronic Minimed | 5 |
| TempoSmart | Welldoc | 4 |
| LivingConnected Diabetes | Welldoc | 4 |
Showing 12 of 36. All products under Calculator, Drug Dose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232451 | 2023-12-12 |
| K202596 | 2021-06-04 |
| K172177 | 2017-11-07 |
| K170669 | 2017-06-19 |
| K161433 | 2016-11-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Voluntis | 510(k) number | 2018-10-08 | Class II | Software in the Use Environment | The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is n | 14 | 2019-03-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.