Pivot App for iOS
iOS smartphone application for Pivot Insulin Delivery System, software version v2.X
7manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Modular Medical, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K253534 |
| Record published | 2026-05-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pivot Insulin Delivery System | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262153 | 2026-09-02 |
| K253534 | 2026-04-08 |
| K240158 | 2024-09-04 |
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.