Eyefeel Ophthalmic Warmer
FDA 510(k) K021843 · Bio-Lipid, Inc.
510(k) numberK021843
Submission
- Device name
- Eyefeel Ophthalmic Warmer
- Applicant
- Bio-Lipid, Inc.
Washington, DC, US - Received
- June 5, 2002
- Decision date
- September 3, 2002
- 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
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 |
| 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 |
| K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD)IMD · Traditional | Allegiance Healthcare Corp. | 04/03/1997SE |
More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K082087 | Eyefeel Ophthalmic WarmerIMD · Traditional | 09/11/2008SE |
Questions and answers
When was Eyefeel Ophthalmic Warmer cleared by the FDA?
Eyefeel Ophthalmic Warmer (K021843) received a 510(k) decision of Substantially Equivalent on September 3, 2002, 90 days after the submission was received.
What is the product code of K021843?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.