FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
577ES (ERGOSENSE)
K Number: K945257
·
Decision Apr 26, 1995
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
8
Review Days
180
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 577ES (ERGOSENSE)
- K Number
- K945257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumex, Inc.
- Date Received
- October 28, 1994
- Decision Date
- April 26, 1995
- Product Code
- INO
- 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 |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INO), ordered by most recent decision date.
DALTON LIFT CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
EASYSTAND BANTAM MEDIUM
FDA 510(k)
FDA Class 2
·Physical Medicine
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
COMPACT WHEELCHAIR PLATFORM
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFT CHAIR, MODEL T3
FDA 510(k)
FDA Class 2
·Physical Medicine
BANTAM
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Lumex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963674 | LUMEX AIR | Jan 10, 1997 | Substantially Equivalent |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | Jul 18, 1996 | Substantially Equivalent |
| K953675 | ALTADYNE | Sep 28, 1995 | Substantially Equivalent |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | May 12, 1995 | Substantially Equivalent |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) | Oct 17, 1994 | Substantially Equivalent |
| K923977 | AKROTECH 4000 | Feb 12, 1993 | Substantially Equivalent |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | Feb 22, 1990 | Substantially Equivalent |