IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
FDA 510(k) clearance K063175 · decided 2008-03-14
Clearance details
- K-number
- K063175
- Device name
- IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
- Applicant
- Medical Technology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-19
- Decision date
- 2008-03-14
- Days to decision
- 512 days
- Clearance type
- Traditional
- Product code
- MOC
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chicago, IL, 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 |
|---|---|---|
| ERGOSEAT SYSTEM (K954162) | Ergo-Air, Inc. | 1995-10-30 |
Recalls involving this device
No recalls on record reference this clearance.