Sur Flo Thermal Therapy Pads
FDA 510(k) K930634 · Buckman Co., Inc.
510(k) numberK930634
Submission
- Device name
- Sur Flo Thermal Therapy Pads
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- February 8, 1993
- Decision date
- November 1, 1993
- 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 Sur Flo Thermal Therapy Pads cleared by the FDA?
Sur Flo Thermal Therapy Pads (K930634) received a 510(k) decision of Substantially Equivalent on November 1, 1993, 266 days after the submission was received.
What is the product code of K930634?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.