The following data is part of a premarket notification filed by Mayborn (uk) Limited with the FDA for Wearable Breast Pump.
| Device ID | K221598 |
| 510k Number | K221598 |
| Device Name: | Wearable Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Mayborn (UK) Limited Mayborn House Balliol Business Park, Newcastle Upon Tyne,, GB NE12 8EW |
| Contact | Sean Neasham |
| Correspondent | Amber Pang Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, 555 West Guangzhong Road Shanghai, CN 200072 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-02 |
| Decision Date | 2022-12-09 |