510(k) K964873
- Device
- SILKAIR LOW AIRLOSS THERAPY
- Applicant
- HILL-ROM, INC.
- 510(k) number
- K964873
- Product code
- IOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-03
- Date received
- 1996-12-05
- Regulation
- 890.5170
- Classification name
- Bed, Flotation Therapy, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWIN BILLS
- Address
- 4349 Corporate Rd. Charleston SC US 29405 29405
FDA Registration Numbers#
- 3008058231
- 3007309299
- 3007005431
- 3003542872
- 8022290
- 1834244
- 3006697241
- 3011489684
- 2030595
- 3017486514
- 3009591865
- 2032121
- 1931307
- 3014650138
- 1824206
- 1954156
- 8043439
- 9710603
- 3010010434
- 3031218453
- 3007420694
- 2030732
- 3036779619
- 1831750
- 3012292104
Source Documents#
Other 510(k) Records For Product Code IOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom | 2015-03-10 |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Hill-Rom | 2013-06-03 |
| K973624 | NURSE'S AID PATIENT ROTATION SYSTEM | Air Med Assist Products | 1998-01-21 |
| K970364 | AIRTEC2 LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | 1997-11-17 |
| K970363 | HYDROTEC LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | 1997-11-17 |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Hill-Rom, Inc. | 1997-08-26 |
| K970295 | FLEXICAIR EXLIPSE PLUS | Hill-Rom, Inc. | 1997-05-16 |
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Numotech, Inc. | 1995-07-31 |
| K951001 | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | 1995-06-27 |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Hill-Rom, Inc. | 1995-02-27 |
| K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | Support Systems Intl. | 1995-02-10 |
| K940662 | I-5000 | Support Systems Intl. | 1994-06-15 |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | 1993-12-21 |
| K932480 | PRISM | Bio Clinic Co. | 1993-07-21 |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Bio Clinic Co. | 1993-06-24 |
Legacy Summary#
summary
FDA Review#
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