FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VOLLMAN PRONE POSITIONER
K Number: K963091
·
Decision Jan 9, 1997
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
4
Applicant Total
33
Review Days
154
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Basic Information
- Device Name
- VOLLMAN PRONE POSITIONER
- K Number
- K963091
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom, Inc.
- Date Received
- August 8, 1996
- Decision Date
- January 9, 1997
- Product Code
- IPT
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IPT | Orthosis, Thoracic | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPT), ordered by most recent decision date.
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LATERAL TRUNK SUPPORTS
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Other Clearances by Hill-Rom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | Mar 4, 2021 | Substantially Equivalent |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | May 7, 2018 | Substantially Equivalent |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Nov 16, 2001 | Substantially Equivalent |
| K973705 | CONTOR TABLE SURFACE | Aug 7, 1998 | Substantially Equivalent |
| K981081 | BRIGHTSTAR | Apr 29, 1998 | Substantially Equivalent |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Feb 2, 1998 | Substantially Equivalent |
| K971366 | INCUWARMER | Jan 5, 1998 | Substantially Equivalent |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Aug 26, 1997 | Substantially Equivalent |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Jul 3, 1997 | Substantially Equivalent |
| K964223 | CLINITRON RITE-HITE | May 28, 1997 | Substantially Equivalent |