FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHA TRI-KART
K Number: K841919
·
Decision May 23, 1984
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
10
Review Days
13
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Basic Information
- Device Name
- ALPHA TRI-KART
- K Number
- K841919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Alpha Unlimited, Inc.
- Date Received
- May 10, 1984
- Decision Date
- May 23, 1984
- 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 Alpha Unlimited, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894646 | #556 DISPOSABLE UMBILICAL CORD CLAMP (2) | Sep 5, 1989 | Substantially Equivalent |
| K893428 | ALPHA SHOPPER | Jun 12, 1989 | Substantially Equivalent |
| K893429 | ALPHA CONDOR | Jun 12, 1989 | Substantially Equivalent |
| K893248 | ALPHA MALLARD | May 26, 1989 | Substantially Equivalent |
| K853766 | ALPHA SUPER KART | Nov 20, 1985 | Substantially Equivalent |
| K841921 | ALPHA PLUS 1 | May 23, 1984 | Substantially Equivalent |
| K841911 | ALPHA PUSH KART | May 23, 1984 | Substantially Equivalent |
| K841912 | ALPHA 4 X 4 | May 23, 1984 | Substantially Equivalent |
| K841920 | MAC-MULTI-ADJUSTABLE CHAIR | May 23, 1984 | Substantially Equivalent |