Model PMT850
FDA 510(k) K070931 · Promedtek, Inc.
510(k) numberK070931
Submission
- Device name
- Model PMT850
- Applicant
- Promedtek, Inc.
Washington, DC, US - Received
- April 3, 2007
- Decision date
- May 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
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Questions and answers
When was Model PMT850 cleared by the FDA?
Model PMT850 (K070931) received a 510(k) decision of Substantially Equivalent on May 24, 2007, 51 days after the submission was received.
What is the product code of K070931?
The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.