Transwarmer
FDA 510(k) K934631 · Prism Technologies, Inc.
510(k) numberK934631
Submission
- Device name
- Transwarmer
- Applicant
- Prism Technologies, Inc.
San Antonio, TX, US - Received
- September 24, 1993
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
Other 510(k)s with product code IMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming MattressIMD · Traditional | International Biomedical | 10/06/2022SE |
| K163295 | Infant Transport Mattress Warmer with DiscIMD · Traditional | Rapid Aid Corp. | 07/24/2017SE |
| K112547 | Neo NestIMD · Traditional | Denovo Proucts, LLC | 03/06/2012SE |
| K082087 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/11/2008SE |
| K071710 | Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)IMD · Traditional | Johnson & Johnson Consumer Products, Inc. | 08/14/2007SE |
| K021843 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/03/2002SE |
| K982652 | Allegiance Porta-Warm MattressIMD · Traditional | Allegiance Healthcare Corp. | 01/21/1999SE |
| K980509 | Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional | Deroyal Industries, Inc. | 02/26/1998SE |
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | Consolidated Products & Services, Inc. | 11/19/1997SE |
| K973770 | Allegiance Kwik Heat Warm Perineal PackIMD · Traditional | Allegiance Healthcare Corp. | 11/13/1997SE |
More from Allegiance Healthcare Corp.
Questions and answers
When was Transwarmer cleared by the FDA?
Transwarmer (K934631) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 132 days after the submission was received.
What is the product code of K934631?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.