Ready-Heat Blanket
FDA 510(k) K042145 · Techtrade, LLC
510(k) numberK042145
Submission
- Device name
- Ready-Heat Blanket
- Applicant
- Techtrade, LLC
Potomac, MD, US - Received
- August 9, 2004
- Decision date
- September 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KME – Bedding, Disposable, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6060
- Specialty
- General Hospital
Other 510(k)s with product code KME
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944953 | Orex Medical BeddingKME · Traditional | Thantex Specialties, Inc. | 12/02/1994SE |
| K933636 | Dispose-A-SheetKME · Traditional | Belmac Healthcare Corp. | 01/26/1994SE |
| K932539 | Doctor Down --Rescue WrapKME · Traditional | Three Dog Down | 11/02/1993SE |
| K922143 | American Burn SheetKME · Traditional | American Silk Sutures, Inc. | 08/10/1992SE |
| K915303 | Foil Baby BuntingKME · Traditional | Gam Industries, Inc. | 02/20/1992SE |
| K912257 | Chem-Sleeve BKME · Traditional | Haz-Med, Inc. | 12/31/1991SE |
| K911953 | Medi Guard Sheets/UnderlaysKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911952 | Medi Guard UnderpadKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911948 | Medi Guard PillowcaseKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911950 | Medi Guard DrapesKME · Traditional | Sancella, Inc. | 05/21/1991SE |
More from Sancella, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050097 | Techno-Scope Visual StethoscopeDQD · Traditional | 09/30/2005SE |
Questions and answers
When was Ready-Heat Blanket cleared by the FDA?
Ready-Heat Blanket (K042145) received a 510(k) decision of Substantially Equivalent on September 17, 2004, 39 days after the submission was received.
What is the product code of K042145?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.