FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K Number: K033438
·
Decision Nov 20, 2003
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
35
Applicant Total
12
Review Days
23
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Basic Information
- Device Name
- BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
- K Number
- K033438
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5150
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bruno Independent Living Aids, Inc.
- Date Received
- October 28, 2003
- Decision Date
- November 20, 2003
- Product Code
- ILK
- 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 |
|---|---|---|---|
| ILK | Transport, Patient, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Bruno Independent Living Aids, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113308 | BRUNO ELAN STAIRWAY ELEVATOR | Feb 1, 2012 | Substantially Equivalent |
| K061514 | BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 | Jul 13, 2006 | Substantially Equivalent |
| K033829 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | Dec 29, 2003 | Substantially Equivalent |
| K033752 | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | Dec 12, 2003 | Substantially Equivalent |
| K022509 | BRUNO ELECTRA-RIDE, MODEL SRE-2700 | Aug 13, 2002 | Substantially Equivalent |
| K011227 | REGAL MOTOTRIZED 3 WHEELED VEHICLE | May 11, 2001 | Substantially Equivalent |
| K002205 | CARONY | Aug 10, 2000 | Substantially Equivalent |
| K991954 | THE BRUNO POWERBASE, MODEL PSB-2200 | Nov 2, 1999 | Substantially Equivalent |
| K970927 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM | Aug 26, 1997 | Substantially Equivalent |
| K921647 | REGAL MOTORIZIED 3 WHEELED VEHICLE | May 4, 1992 | Substantially Equivalent |