FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ROAD WARRIOR
K Number: K935749
·
Decision Jan 13, 1995
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
16
Review Days
413
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Basic Information
- Device Name
- ROAD WARRIOR
- K Number
- K935749
- 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
- November 26, 1993
- Decision Date
- January 13, 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 |
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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 |
| K940920 | ROAD SAVAGE | Feb 3, 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 |