Levator Elite (Model LE9011)
FDA 510(k) K213043 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK213043
Submission
- Device name
- Levator Elite (Model LE9011)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN - Received
- September 22, 2021
- Decision date
- February 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
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| K210364 | Migraine Tens Digital Pain RelieverPCC · Traditional | 06/17/2021SE |
| K180331 | Wireless Pain Relieve DeviceNUH · Traditional | 06/22/2018SE |
| K171430 | Incontinence Treatment Device, Model LT2061KPI · Traditional | 03/15/2018SE |
| K173462 | Wireless Pain Relieve Device Model: LT5018CNUH · Special | 12/08/2017SE |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10IPF · Traditional | 10/02/2017SE |
| K162479 | Smart Pain Reliever, Model LT5019NUH · Traditional | 02/08/2017SE |
| K161735 | Non-contact Forehead ThermometerFLL · Traditional | 11/17/2016SE |
| K150436 | ComboRehabIMG · Traditional | 11/13/2015SE |
Questions and answers
When was Levator Elite (Model LE9011) cleared by the FDA?
Levator Elite (Model LE9011) (K213043) received a 510(k) decision of Substantially Equivalent on February 25, 2022, 156 days after the submission was received.
What is the product code of K213043?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.