Wearable Breast Pump (Model S18)
Summary
Shenzhen TPH Technology Co., Ltd. received 510(k) clearance for Wearable Breast Pump (Model S18), a HGX device. Cleared on 2023-07-14.
Details
Source
510(k) Clearance
External ID
K223886
Action Date
2023-07-14
Status
Traditional
Category
device
Product Code
HGX
Product Description
Wearable Breast Pump (Model S18). Product code: HGX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Shenzhen TPH Technology Co., Ltd. has received 21 total clearances in our database.
Shenzhen TPH Technology Co., Ltd. has 21 FDA actions in our database, including 21 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Shenzhen TPH Technology Co., Ltd. have FDA actions?
Shenzhen TPH Technology Co., Ltd. has 21 FDA actions in our database, including 0 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223886" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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