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 | March 12, 1992 |
| K813226 | jefferson industries | GEL FLOTATION MATTRESS | December 2, 1981 |
| K802833 | tetra group u.s.a | TETRA NATAL-MAT WATER FLOTATION MAT. | December 10, 1980 |
| K802781 | leemart bedding mfg | BEDDING PADS EGGCREATE PADS | December 10, 1980 |
| K780779 | jefferson industries | ECONO-FLOAT WATER FLOTATION MATTRESS | May 19, 1978 |
| K772062 | medpro | NEONATAL FLOTATION SYSTEM | November 15, 1977 |
| K771824 | medpro | MEDPRO FLOTATION SYSTEM | October 19, 1977 |
| K760963 | arco medical products | DECUBITUS MATTRESS | November 18, 1976 |