FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARRETTE 3 WHEELED MOTORIZED CART
K Number: K891609
·
Decision Apr 6, 1989
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
30
Review Days
17
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Basic Information
- Device Name
- CARRETTE 3 WHEELED MOTORIZED CART
- K Number
- K891609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Everest & Jennings, Inc.
- Date Received
- March 20, 1989
- Decision Date
- April 6, 1989
- 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 Everest & Jennings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925865 | KID POWER | Mar 28, 1994 | Substantially Equivalent |
| K940303 | RECORD | Feb 17, 1994 | Substantially Equivalent |
| K940304 | NITRO | Feb 17, 1994 | Substantially Equivalent |
| K930413 | PREMIER CLASSIC | Mar 31, 1993 | Substantially Equivalent |
| K930412 | PREMIER 2 WHEELCHAIR | Mar 31, 1993 | Substantially Equivalent |
| K930411 | UNIVERSAL WHEELCHAIR | Mar 31, 1993 | Substantially Equivalent |
| K913645 | SPECIALTY CONTROLS INTERFACE | Dec 17, 1991 | Substantially Equivalent |
| K914091 | POWER RECLINER WHEELCHAIR | Nov 19, 1991 | Substantially Equivalent |
| K905621 | ELLIPSE 2.3 | Dec 21, 1990 | Substantially Equivalent |
| K904958 | TEMPEST ELECTRIC WHEELCHAIR | Nov 26, 1990 | Substantially Equivalent |