CT2011 Sonicstimu Pain Relief Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092627 FDA 510(k)
- FDA Product Code
- IMG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5860 FDA 510(k)
- Regulation Number
- 890.5860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ct2011 Sonicstimu Pain Relief Device is a stimulator, ultrasound and muscle, for use in applying therapeutic deep heat. It provides pain relief through a combination of ultrasound and transcutaneous electrical nerve stimulation technology.
The device is supplied by Shenzhen Dongdixin Technology Co., Ltd. and is classified as a class 2 device. It has a product code of IMG and a regulation number of 890.5860. The device has been cleared with a Traditional 510K clearance and has a K number of K092627.
Frequently asked questions
What is the CT2011 Sonicstimu Pain Relief Device used for?
The CT2011 Sonicstimu Pain Relief Device is used for applying therapeutic deep heat and providing pain relief through a combination of ultrasound and transcutaneous electrical nerve stimulation technology.
Is the CT2011 Sonicstimu Pain Relief Device a single-use or reusable device?
The device description does not specify whether it is single-use or reusable, but it is classified as a class 2 device with a product code of IMG.
What is the regulatory status of the CT2011 Sonicstimu Pain Relief Device?
The device has been cleared with a Traditional 510K clearance, with a K number of K092627, indicating that it is substantially equivalent to a predicate device.
What type of technology does the CT2011 Sonicstimu Pain Relief Device use?
The device uses a combination of ultrasound and transcutaneous electrical nerve stimulation technology to provide pain relief.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SonicStimu CT2011 User Manual | PDF | Computing | Digital Technology, TENSCARE SONICSTIMU CT2011 MANUAL Pdf Download | ManualsLib, CT2011 SONICSTIMU PAIN RELIEF DEVICE - Innolitics, TENSCARE SONICSTIMU CT2011 MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092627 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (1)
- FDA 510(k) K092627 24 fields · synced Sep 21, 2026