ProMedTek Model C1400 Shortwave Diathermy Device
FDA 510(k) K162240 · Promedtek, Inc.
510(k) numberK162240
Submission
- Device name
- ProMedTek Model C1400 Shortwave Diathermy Device
- Applicant
- Promedtek, Inc.
Scottsdale, AZ, US - Received
- August 9, 2016
- Decision date
- November 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
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| K173300 | ViaTherm BOOSTIMJ · Traditional | Viatherm Therapeutics, LLC | 05/01/2018SE |
| K161862 | ThermoProIMJ · Traditional | Zimmer Medizinsysteme GmbH | 11/14/2016SE |
| K153456 | Megapulse III Shortwave DiathermyIMJ · Traditional | Accelerated Care Plus | 06/14/2016SE |
| K131926 | ThermopulseIMJ · Traditional | Ibramed Equipamentos Medicos | 07/24/2014SE |
| K131899 | Sw-ThermIMJ · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 03/14/2014SE |
More from Shenzhen Dongdixin Technology Co., Ltd.
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|---|---|---|
| K070931 | Model PMT850ILX · Traditional | 05/24/2007SE |
Questions and answers
When was ProMedTek Model C1400 Shortwave Diathermy Device cleared by the FDA?
ProMedTek Model C1400 Shortwave Diathermy Device (K162240) received a 510(k) decision of Substantially Equivalent on November 17, 2016, 100 days after the submission was received.
What is the product code of K162240?
The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.