IKY — Mattress, Flotation Therapy, Non-Powered Class I
FDA product code IKY covers "Mattress, Flotation Therapy, Non-Powered", a Class I medical device regulated under 21 CFR 880.5150. Submissions are reviewed by the General Hospital panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKY
- Device Class
- Class I
- Regulation Number
- 880.5150
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914921 | Gaymar Industries | SCM-3 AND ACCESSORIES | Mar 12, 1992 |
| K813226 | Jefferson Industries | GEL FLOTATION MATTRESS | Dec 2, 1981 |
| K802781 | Leemart Bedding Mfg | BEDDING PADS EGGCREATE PADS | Dec 10, 1980 |
| K802833 | Tetra Group U.S.A | TETRA NATAL-MAT WATER FLOTATION MAT. | Dec 10, 1980 |
| K780779 | Jefferson Industries | ECONO-FLOAT WATER FLOTATION MATTRESS | May 19, 1978 |
| K772062 | Medpro | NEONATAL FLOTATION SYSTEM | Nov 15, 1977 |
| K771824 | Medpro | MEDPRO FLOTATION SYSTEM | Oct 19, 1977 |
| K760963 | Arco Medical Products | DECUBITUS MATTRESS | Nov 18, 1976 |