I-5000
FDA 510(k) clearance K940662 · decided 1994-06-15
Clearance details
- K-number
- K940662
- Device name
- I-5000
- Applicant
- Support Systems Intl.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-18
- Decision date
- 1994-06-15
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- IOQ
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Charleston, SC, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.