FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ROAD SAVAGE
K Number: K940920
·
Decision Feb 3, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
16
Review Days
343
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
- ROAD SAVAGE
- K Number
- K940920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Redman, Inc.
- Date Received
- February 25, 1994
- Decision Date
- February 3, 1995
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
Power Wheelchair (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Redman, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935750 | GERONIMO | Feb 3, 1995 | Substantially Equivalent for Some Indications |
| K940851 | RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT | Feb 3, 1995 | Substantially Equivalent for Some Indications |
| K940852 | CHIEF STANDUP WHEELCHAIR | Feb 3, 1995 | Substantially Equivalent for Some Indications |
| K940919 | CHIEF SR | Feb 3, 1995 | Substantially Equivalent for Some Indications |
| K935751 | GERONIMO PR | Feb 3, 1995 | Substantially Equivalent for Some Indications |
| K935749 | ROAD WARRIOR | Jan 13, 1995 | Substantially Equivalent for Some Indications |
| K870298 | REDMAN ACCESSORIES | Feb 26, 1987 | Substantially Equivalent |
| K870296 | MOHAVE MODEL 102W WHEELCHAIR | Feb 10, 1987 | Substantially Equivalent |
| K870292 | CHEYENNE MODEL 107A WHEELCHAIR | Feb 10, 1987 | Substantially Equivalent |
| K870291 | CHEROKEE MODEL 102A WHEELCHAIR | Feb 10, 1987 | Substantially Equivalent |