Ice-Pak, Pdi
FDA 510(k) K780279 · Nice-Pak Products, Inc.
510(k) numberK780279
Submission
- Device name
- Ice-Pak, Pdi
- Applicant
- Nice-Pak Products, Inc.
Mchenry, IL, US - Received
- February 21, 1978
- Decision date
- April 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K974768 | Pdi Sterile Lubricating JellyKMJ · Traditional | 01/16/1998SE |
| K840343 | Pdi Prepmaster Wet Pack VAGINAL-X21477KGO · Traditional | 03/27/1984SE |
| K840342 | Pdi Prepmaster Wet Pack Patient Prep KitFRG · Traditional | 03/27/1984SE |
| K840344 | Pdi Prepmaster Wet Pack Minor ProcedureFRG · Traditional | 03/26/1984SE |
| K833549 | Pdi Surgical Scrub/Brush T150-70NAB · Traditional | 11/28/1983SE |
| K810337 | Pdi Surgical Scrub SPONGE-BRUSH-T15070GEC · Traditional | 02/26/1981SE |
| K781539 | Iso-Care KitHMP · Traditional | 11/03/1978SE |
| K780400 | Den-Z-OrbKHR · Traditional | 03/27/1978SE |
Questions and answers
When was Ice-Pak, Pdi cleared by the FDA?
Ice-Pak, Pdi (K780279) received a 510(k) decision of Substantially Equivalent on April 10, 1978, 48 days after the submission was received.
What is the product code of K780279?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.