Product code IKY
- Device name
- Mattress, Flotation Therapy, Non-Powered
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5150
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | 1992-03-12 |
| K813226 | GEL FLOTATION MATTRESS | Jefferson Industries, Inc. | 1981-12-02 |
| K802781 | BEDDING PADS EGGCREATE PADS | Leemart Bedding Mfg. Co. | 1980-12-10 |
| K802833 | TETRA NATAL-MAT WATER FLOTATION MAT. | Tetra Group U.S.A., Inc. | 1980-12-10 |
| K780779 | ECONO-FLOAT WATER FLOTATION MATTRESS | Jefferson Industries, Inc. | 1978-05-19 |
| K772062 | NEONATAL FLOTATION SYSTEM | Medpro, Inc. | 1977-11-15 |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | 1977-10-19 |
| K760963 | DECUBITUS MATTRESS | Arco Medical Products Co. | 1976-11-18 |
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| 08592654851074 | Ergozone 3000 | L I N E T spol. s r.o. | 2025-11-03 |
| 08592654851067 | Ergozone 3000 | L I N E T spol. s r.o. | 2025-11-03 |
| 00841447115175 | Invacare® Softform Premier Foam Mattress | INVACARE CORPORATION | 2025-10-10 |
| 00841447115205 | Invacare® Softform Premier Foam Mattress | INVACARE CORPORATION | 2025-10-10 |
| 00841447115199 | Invacare® Softform Premier Foam Mattress | INVACARE CORPORATION | 2025-10-10 |
| 00841447115182 | Invacare® Softform Premier Foam Mattress | INVACARE CORPORATION | 2025-10-10 |
| 05056147701503 | Accora Allevia Comfort | ACCORA LIMITED | 2025-09-30 |
| 05056147701497 | Accora Allevia Comfort | ACCORA LIMITED | 2025-09-30 |
| H93331629 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2025-09-04 |
| 08592654851050 | Ergozone 7000 | L I N E T spol. s r.o. | 2025-06-24 |
| 08592654851043 | Ergozone 5000 | L I N E T spol. s r.o. | 2025-06-24 |
| 08592654851036 | Ergozone 3000 | L I N E T spol. s r.o. | 2025-06-24 |
| H933W84352910PK0 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | 2024-04-03 |
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| 10603354100128 | WAFFLE | EHOB INC | 2020-08-21 |
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| 04713616092708 | NA | CARILEX MEDICAL, INC. | 2017-03-22 |
| 07613327288575 | NA | STRYKER CORPORATION | 2016-09-24 |
| 00887761998339 | Excel Care® Surface | HILL-ROM, INC. | 2016-09-17 |