FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
K Number: K900042
·
Decision Jan 12, 1990
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
27
Review Days
10
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Basic Information
- Device Name
- FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
- K Number
- K900042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fortress Scientific , Ltd.
- Date Received
- January 2, 1990
- Decision Date
- January 12, 1990
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K933856 | A921 12 VOLT POWER SOCKET | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K933853 | A901 TILT IN SPACE | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K930088 | FORTRESS C-500 MICROPROCESSOR CONTROLLER | Mar 28, 1994 | Substantially Equivalent |
| K933860 | S480 SEATING SYSTEM | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K932597 | FORTRESS C-300 MICROPROCESSOR CONTROLLER | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K933864 | 720 POWER BASE | Mar 28, 1994 | Substantially Equivalent |
| K933854 | 770 POWER BASE | Mar 28, 1994 | Substantially Equivalent for Some Indications |