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MyOnyx System

by Thought Technology Ltd.

510(k) K201014

MyOnyx System is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K201014 on 13 Jan 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201014 Date13 Jan 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPI
FDA applicant
Thought Technology , Ltd.
Device class
Class II
Regulation
21 CFR Part 876.5320
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K201014

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201014
UDI-DISize and differences
MyOnyx Mobile App SA9030
Thought Technology Ltd.
SA903007540191000586
Prescription: no; Single use: no
On the market
MyOnyx SA9020
Thought Technology Ltd.
SA902007540191000593
Prescription: no; Single use: no
On the market
Pressure Sensor SA9003
Thought Technology Ltd.
SA900307540191000609
Prescription: yes; Single use: no
On the market
Vaginal Pressure Probe SA9005
Thought Technology Ltd.
SA900507540191000616
Prescription: yes; Single use: yes
On the market

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →