ThermoPro
FDA 510(k) K161862 · Zimmer Medizinsysteme GmbH
510(k) numberK161862
Submission
- Device name
- ThermoPro
- Applicant
- Zimmer Medizinsysteme GmbH
Neu-Ulm, DE - Received
- July 6, 2016
- Decision date
- November 14, 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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| K182363 | BTL-703IMJ · Traditional | BTL Industries, Inc. | 01/24/2019SE |
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| 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 |
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Questions and answers
When was ThermoPro cleared by the FDA?
ThermoPro (K161862) received a 510(k) decision of Substantially Equivalent on November 14, 2016, 131 days after the submission was received.
What is the product code of K161862?
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.