FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SC930 SEAT CONTROLLER
K Number: K933859
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
27
Review Days
234
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Basic Information
- Device Name
- SC930 SEAT CONTROLLER
- K Number
- K933859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Fortress Scientific , Ltd.
- Date Received
- August 6, 1993
- Decision Date
- March 28, 1994
- 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 Fortress Scientific , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K933855 | S490 SEATING SYSTEM | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K933861 | S860 SEATING SYSTEM | Mar 28, 1994 | Substantially Equivalent |
| 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 |
| K933858 | 730 POWER BASE | Mar 28, 1994 | Substantially Equivalent for Some Indications |