Decubitus Mattress
FDA 510(k) K760963 · Arco Medical Products Co.
510(k) numberK760963
Submission
- Device name
- Decubitus Mattress
- Applicant
- Arco Medical Products Co.
Walker, MI, US - Received
- November 4, 1976
- Decision date
- November 18, 1976
- 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 |
| K802781 | Bedding Pads Eggcreate PadsIKY · Traditional | Leemart Bedding Mfg. Co. | 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 |
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| K800838 | Arcolith 3022&ARCOLITH 3023 Cardiac Gen.DXY · Traditional | 06/04/1980SE |
| K800326 | Arcolith 3021-CARDIAC Pulse GeneratorDXY · Traditional | 03/17/1980SE |
| K792299 | Arcolith 3020-CARDIAC Pulse GeneratorDXY · Traditional | 11/29/1979SE |
| K792216 | Arcolith 2100-CARDIAC Pulse GeneratorDXY · Traditional | 11/29/1979SE |
| K791715 | Arcolith 2000DXY · Traditional | 09/27/1979SE |
| K791147 | Arco Progammable Pacemaker SystemDXY · Traditional | 08/03/1979SE |
Questions and answers
When was Decubitus Mattress cleared by the FDA?
Decubitus Mattress (K760963) received a 510(k) decision of Substantially Equivalent on November 18, 1976, 14 days after the submission was received.
What is the product code of K760963?
The FDA product code is IKY – Mattress, Flotation Therapy, Non-Powered, a Class I (low risk) device regulated under 21 CFR 880.5150.