510(k) K063175
- Device
- IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
- Applicant
- Medical Technology Systems, Inc.
- 510(k) number
- K063175
- Product code
- MOC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-14
- Date received
- 2006-10-19
- Regulation
- 890.5170
- Classification name
- Cushion, Flotation, Therapeutic
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELLIS K NAM
- Address
- 6101 N. Sheridan Rd. Suite 40d Chicago IL US 60660 60660
FDA Registration Numbers#
- 3010526655
- 2030595
- 3010603857
- 3008466086
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MOC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954162 | ERGOSEAT SYSTEM | Ergo-Air, Inc. | 1995-10-30 |