FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CELEBRITY SC440
K Number: K930953
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
19
Review Days
398
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Basic Information
- Device Name
- CELEBRITY SC440
- K Number
- K930953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Pride Health Care, Inc.
- Date Received
- February 23, 1993
- Decision Date
- March 28, 1994
- 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 Pride Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945936 | JAZZY | May 28, 1996 | Substantially Equivalent |
| K944940 | EURO SC500 | Feb 12, 1996 | Substantially Equivalent |
| K953342 | TMR48 | Sep 8, 1995 | Substantially Equivalent |
| K944277 | DYNAMO | Dec 28, 1994 | Substantially Equivalent for Some Indications |
| K944939 | CELEBRITY XL SC445 | Nov 7, 1994 | Substantially Equivalent |
| K931231 | SIDEKICK II | May 5, 1994 | Substantially Equivalent for Some Indications |
| K926295 | LEGEND SC 300 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K930952 | PRIDE LEGEND SC-340 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K926296 | CELEBRITY SC400 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K926499 | SHUTTLE SC-140 | Mar 28, 1994 | Substantially Equivalent |