IKY · Mattress, Flotation Therapy, Non-Powered
General Hospital · 21 CFR 880.5150 · Class 1
Overview
| Product Code | IKY |
|---|---|
| Device Name | Mattress, Flotation Therapy, Non-Powered |
| Regulation | 21 CFR 880.5150 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | Mar 12, 1992 | SESE |
| K813226 | GEL FLOTATION MATTRESS | Jefferson Industries, Inc. | Dec 2, 1981 | SESE |
| K802833 | TETRA NATAL-MAT WATER FLOTATION MAT. | Tetra Group U.S.A., Inc. | Dec 10, 1980 | SESE |
| K802781 | BEDDING PADS EGGCREATE PADS | Leemart Bedding Mfg. Co. | Dec 10, 1980 | SESE |
| K780779 | ECONO-FLOAT WATER FLOTATION MATTRESS | Jefferson Industries, Inc. | May 19, 1978 | SESE |
| K772062 | NEONATAL FLOTATION SYSTEM | Medpro, Inc. | Nov 15, 1977 | SESE |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | Oct 19, 1977 | SESE |
| K760963 | DECUBITUS MATTRESS | Arco Medical Products Co. | Nov 18, 1976 | SESE |
Top Applicants
- Jefferson Industries, Inc. — 2 clearances
- Medpro, Inc. — 2 clearances
- Arco Medical Products Co. — 1 clearance
- Gaymar Industries, Inc. — 1 clearance
- Leemart Bedding Mfg. Co. — 1 clearance
