FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRIC MOBILITY'S SPARKY
K Number: K874739
·
Decision Apr 22, 1988
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
8
Review Days
156
Basic Information
- Device Name
- ELECTRIC MOBILITY'S SPARKY
- K Number
- K874739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- ELECTRIC MOBILITY CORP.
- Date Received
- November 18, 1987
- Decision Date
- April 22, 1988
- 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 ELECTRIC MOBILITY CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K092130 | RASCAL WE GO 250 POWERED WHEELCHAIR | Sep 21, 2009 | Substantially Equivalent |
| K002616 | ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS | Dec 11, 2000 | Substantially Equivalent |
| K991281 | ELECTRIC MOBILITY CAVALIER SCOOTERS | Oct 27, 1999 | Substantially Equivalent |
| K972370 | RASCAL POWER CHAIR | Nov 14, 1997 | Substantially Equivalent |
| K943936 | XLT, REA COMFORT, SPIREA, ZOOM | Sep 21, 1994 | Substantially Equivalent |
| K924515 | ELECTRIC MOBILITY RASCAL | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K882669 | APPOLLO BATH | Jul 8, 1988 | Substantially Equivalent |