TTU-100THERMAL Therapy Unit
FDA 510(k) K913026 · Danninger Medical Technology, Inc.
510(k) numberK913026
Submission
- Device name
- TTU-100THERMAL Therapy Unit
- Applicant
- Danninger Medical Technology, Inc.
Concord, CA, US - Received
- July 9, 1991
- Decision date
- December 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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Questions and answers
When was TTU-100THERMAL Therapy Unit cleared by the FDA?
TTU-100THERMAL Therapy Unit (K913026) received a 510(k) decision of Substantially Equivalent on December 13, 1991, 157 days after the submission was received.
What is the product code of K913026?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.