Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
Summary
Wuxi Jiajian Medical Instrument Co., Ltd. received 510(k) clearance for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1), a NUH device. Cleared on 2024-03-27.
Details
Source
510(k) Clearance
External ID
K231425
Action Date
2024-03-27
Status
Traditional
Category
device
Product Code
NUH
Product Description
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1). Product code: NUH.
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. Wuxi Jiajian Medical Instrument Co., Ltd. has received 4 total clearances in our database.
Wuxi Jiajian Medical Instrument Co., Ltd. has 4 FDA actions in our database, including 4 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 Wuxi Jiajian Medical Instrument Co., Ltd. have FDA actions?
Wuxi Jiajian Medical Instrument Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231425" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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