FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECORD
K Number: K940303
·
Decision Feb 17, 1994
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
30
Review Days
24
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Basic Information
- Device Name
- RECORD
- K Number
- K940303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Everest & Jennings, Inc.
- Date Received
- January 24, 1994
- Decision Date
- February 17, 1994
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Everest & Jennings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925865 | KID POWER | Mar 28, 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 |
| K904818 | XCALIBER | Nov 7, 1990 | Substantially Equivalent |