NTX100 Tonic Motor Activation (NTX100 ToMAc) System
Summary
Noctrix Health, Inc. received 510(k) clearance for NTX100 Tonic Motor Activation (NTX100 ToMAc) System, a QWD device. Cleared on 2023-04-17.
Details
Source
510(k) Clearance
External ID
DEN220059
Action Date
2023-04-17
Status
Direct
Category
device
Product Code
QWD
Product Description
NTX100 Tonic Motor Activation (NTX100 ToMAc) System. Product code: QWD.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month.
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 Noctrix Health, Inc. have FDA actions?
This is the only FDA action we have on record for Noctrix Health, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN220059" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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