Bedding Pads Eggcreate Pads
FDA 510(k) K802781 · Leemart Bedding Mfg. Co.
510(k) numberK802781
Submission
- Device name
- Bedding Pads Eggcreate Pads
- Applicant
- Leemart Bedding Mfg. Co.
Mchenry, IL, US - Received
- November 5, 1980
- Decision date
- December 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKY – Mattress, Flotation Therapy, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5150
- Specialty
- General Hospital
Other 510(k)s with product code IKY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914921 | SCM-3 and AccessoriesIKY · Traditional | Gaymar Industries, Inc. | 03/12/1992SE |
| K813226 | Gel Flotation MattressIKY · Traditional | Jefferson Industries, Inc. | 12/02/1981SE |
| K802833 | Tetra Natal-Mat Water Flotation Mat.IKY · Traditional | Tetra Group U.S.A., Inc. | 12/10/1980SE |
| K780779 | Econo-Float Water Flotation MattressIKY · Traditional | Jefferson Industries, Inc. | 05/19/1978SE |
| K772062 | Neonatal Flotation SystemIKY · Traditional | Medpro, Inc. | 11/15/1977SE |
| K771824 | Medpro Flotation SystemIKY · Traditional | Medpro, Inc. | 10/19/1977SE |
| K760963 | Decubitus MattressIKY · Traditional | Arco Medical Products Co. | 11/18/1976SE |
Questions and answers
When was Bedding Pads Eggcreate Pads cleared by the FDA?
Bedding Pads Eggcreate Pads (K802781) received a 510(k) decision of Substantially Equivalent on December 10, 1980, 35 days after the submission was received.
What is the product code of K802781?
The FDA product code is IKY – Mattress, Flotation Therapy, Non-Powered, a Class I (low risk) device regulated under 21 CFR 880.5150.