TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
FDA 510(k) clearance K122473 · decided 2013-06-03
Clearance details
- K-number
- K122473
- Device name
- TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
- Applicant
- Hill-Rom
- Decision
- Substantially Equivalent
- Date received
- 2012-08-14
- Decision date
- 2013-06-03
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- IOQ
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Batesville, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hill-Rom Wireless Connectivity Module (K143414) | Hill-Rom | 2015-03-10 |
| NURSE'S AID PATIENT ROTATION SYSTEM (K973624) | Air Med Assist Products | 1998-01-21 |
| HYDROTEC LOW AIR LOSS THERAPY BED (K970363) | Apex Metal, Inc. | 1997-11-17 |
| AIRTEC2 LOW AIR LOSS THERAPY BED (K970364) | Apex Metal, Inc. | 1997-11-17 |
| TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (K970636) | Hill-Rom, Inc. | 1997-08-26 |
| SILKAIR LOW AIRLOSS THERAPY (K964873) | Hill-Rom, Inc. | 1997-07-03 |
| FLEXICAIR EXLIPSE PLUS (K970295) | Hill-Rom, Inc. | 1997-05-16 |
| TOTAL CONTACT SEAT RIPPLE SYSTEM (K943433) | Numotech, Inc. | 1995-07-31 |
| FLEXICAIR EXLIPSE (K951001) | Hill-Rom, Inc. | 1995-06-27 |
| DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE (K945729) | Hill-Rom, Inc. | 1995-02-27 |
| CLENSICAIR LOW AIRLOSS HYDROTHERAPY (K941610) | Support Systems Intl. | 1995-02-10 |
| I-5000 (K940662) | Support Systems Intl. | 1994-06-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complic recall (Z-1468-2025) | Baxter Healthcare Corporation | 2025-03-26 |
| HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000 recall (Z-0212-2024) | Baxter Healthcare Corporation | 2023-11-02 |