FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MECHANICAL WHEELCHAIR 890.3850
K Number: K945175
·
Decision May 12, 1995
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
8
Review Days
203
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Basic Information
- Device Name
- MECHANICAL WHEELCHAIR 890.3850
- K Number
- K945175
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lumex, Inc.
- Date Received
- October 21, 1994
- Decision Date
- May 12, 1995
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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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 |
| K945257 | 577ES (ERGOSENSE) | Apr 26, 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 |