TOTALCARE
FDA 510(k) clearance K962942 · decided 1997-02-03
Clearance details
- K-number
- K962942
- Device name
- TOTALCARE
- Applicant
- Hill-Rom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-29
- Decision date
- 1997-02-03
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- FNL
- Device class
- 2
- Regulation number
- 880.5100
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| iBed Wireless with iBed Mobile (K202964) | Stryker Corporation | 2021-06-18 |
| IBED WIRELESS WITH IBED AWARENESS (K103536) | Stryker Corporation | 2010-12-16 |
| VAIL 1000 ENCLOSED BED (K982783) | Vail Products, Inc. | 1998-10-05 |
| MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (K974296) | Invacare Corp. | 1998-01-06 |
| BENEFIT B3--- SERIES (K974254) | M.C. Healthcare Products, Inc. | 1997-12-16 |
| VOLKER HOSPITAL BED, MODEL K960 (K972115) | Volker Healthcare, Inc. | 1997-08-29 |
| SOMA 900 TRANSPORT BED (K971546) | Nova Technologies, Inc. | 1997-07-10 |
| VAIL 2000 ENCLOSED BED (K963622) | Vail Products, Inc. | 1997-05-07 |
| VAIL 3000 BED ENCLOSURE (K963589) | Vail Products, Inc. | 1997-04-21 |
| SOMA SAFE ENCLOSURE (K963701) | Nova Technology Corp. | 1997-01-24 |
| NOVABED PATIENT TRANSFER SYSTEM (K964246) | Nova Technology Corp. | 1997-01-22 |
| ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 (K964515) | M.C. Healthcare Products, Inc. | 1996-12-31 |
Recalls involving this device
No recalls on record reference this clearance.