UltraTENS
FDA 510(k) K142976 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK142976
Submission
- Device name
- UltraTENS
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN - Received
- October 14, 2014
- Decision date
- August 26, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Specialty
- Physical Medicine
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|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional | 06/26/2026SE |
| K240358 | ShockPhysio Mobile (model SW3200 Basic)ISA · Traditional | 06/05/2024SE |
| K213043 | Levator Elite (Model LE9011)IPF · Traditional | 02/25/2022SE |
| 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 |
Questions and answers
When was UltraTENS cleared by the FDA?
UltraTENS (K142976) received a 510(k) decision of Substantially Equivalent on August 26, 2015, 316 days after the submission was received.
What is the product code of K142976?
The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.