FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
K Number: K983407
·
Decision Nov 6, 1998
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
2
Review Days
39
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Basic Information
- Device Name
- ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
- K Number
- K983407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aceme Technologies Intl.
- Date Received
- September 28, 1998
- Decision Date
- November 6, 1998
- 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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Other Clearances by Aceme Technologies Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K983405 | ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50 | Nov 6, 1998 | Substantially Equivalent |