TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2— 510(k) K122473
Substantially EquivalentHill-Rom
FDA 510(k) clearance K122473 for TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2, Substantially Equivalent on 2013-06-03. Applicant: Hill-Rom. Device class: 2.
Clearance details
- Applicant
- Hill-Rom
- Product code
- Code IOQ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5170
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, IN, US
Recent devices under product code IOQ
view allAdverse events under product code IOQ
product code IOQ- Malfunction
- 676
- Other
- 5
- Total
- 681
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K122473
K-number listed on FDA's recall record- Z-1468-2025 — Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
- Z-0212-2024 — HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122473.
Data sourced from openFDA. This site is unofficial and independent of the FDA.