ORTHODERM CONVERTIBLE
FDA 510(k) clearance K894353 · decided 1989-08-09
Clearance details
- K-number
- K894353
- Device name
- ORTHODERM CONVERTIBLE
- Applicant
- Health Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-08-09
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- IOQ
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Houston, TX, 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 |
| TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 (K122473) | Hill-Rom | 2013-06-03 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.