Allegiance Porta-Warm Mattress
FDA 510(k) K982652 · Allegiance Healthcare Corp.
510(k) numberK982652
Submission
- Device name
- Allegiance Porta-Warm Mattress
- Applicant
- Allegiance Healthcare Corp.
Mcgraw Park, IL, US - Received
- July 30, 1998
- Decision date
- January 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
| 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 |
| K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD)IMD · Traditional | Allegiance Healthcare Corp. | 04/03/1997SE |
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|---|---|---|
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| K023602 | Small Volume NebulizerCAF · Special | 05/01/2003SE |
| K023419 | Trilaminate Drapes/TiburonKKX · Traditional | 02/11/2003SE |
| K024120 | Modification to Temno Biopsy NeedlesFCG · Special | 01/15/2003SE |
| K024292 | Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and…LYY · Special | 01/09/2003SE |
| K024102 | Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimLYY · Special | 12/18/2002SE |
| K023425 | Drapes with Absorbent ReinforcementKKX · Special | 11/06/2002SE |
| K022765 | Nitrile Powder-Free Examination GlovesLZA · Traditional | 10/11/2002SE |
| K023170 | Nitrile Powder-Free Examination GlovesLZA · Special | 10/09/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | 10/02/2002SE |
Questions and answers
When was Allegiance Porta-Warm Mattress cleared by the FDA?
Allegiance Porta-Warm Mattress (K982652) received a 510(k) decision of Substantially Equivalent on January 21, 1999, 175 days after the submission was received.
What is the product code of K982652?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.