FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AKROTECH 4000
K Number: K923977
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
8
Review Days
189
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Basic Information
- Device Name
- AKROTECH 4000
- K Number
- K923977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lumex, Inc.
- Date Received
- August 7, 1992
- Decision Date
- February 12, 1993
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | 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 |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | May 12, 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 |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | Feb 22, 1990 | Substantially Equivalent |