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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810055884568 | MATT 36X80 ELITE-G 500 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884704 | MATT 42X84 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884681 | MATT 42X84 ELITE-G 500 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884674 | MATT 36X80 DELUXE SW STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884643 | MATT 42X80 DELUXE SW STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884636 | MATT 39X80 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884612 | MATT 42X80 ELITE-G SW 500 STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884599 | MATT 35X84 ELITE-G 500 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884582 | MATT 35X76 ELITE-G SW 500 STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884575 | MATT 35X80 ELITE-G 600 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884414 | MATT 35X80 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884551 | MATT 36X80 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884544 | MATT 35X76 DELUXE SW STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884520 | 35X84 ELITE-G 500 STR ZIP COV INC BAR,CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884421 | MATT 35X80 ELITE 500-G LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884438 | 35X80 ELITE-G 500 STR ZIP COV INC BAR,CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884445 | MATT 35X76 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884452 | MATT 42X80 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884469 | MATT 42X80 ELITE-G 500 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884476 | MATT 35X80 DELUXE SW STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884483 | MATT 35X80 ELITE-G SW 500 STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884490 | MATT 35X80 BASIC STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884506 | MATT 35X76 ELITE-G 500 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884513 | MATT 35X84 DELUXE STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884537 | MATT 42X80 ELITE-G 600 LBS STR ZIP COV C | JOERNS HEALTHCARE, LLC | 2026-08-16 |
| 00810055884605 | MATT 54X84 BARIATRIC 1000 STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-15 |
| 00810055884629 | MATT 48X84 BARIATRIC 1000 STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-15 |
| 00810055884650 | MATT 54X80 BARIATRIC 1000 STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-15 |
| 00810055884667 | MATT 48X80 BARIATRIC 1000 STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-15 |
| 00810055884698 | MATT 42X80 BARIATRIC 1000 STR ZIP COV CA | JOERNS HEALTHCARE, LLC | 2026-08-15 |