FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
K Number: K052008
·
Decision Sep 16, 2005
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
10
Review Days
53
Basic Information
- Device Name
- IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
- K Number
- K052008
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- IMC-HEARTWAY, LLC
- Date Received
- July 25, 2005
- Decision Date
- September 16, 2005
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by IMC-HEARTWAY, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K063328 | IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) | Apr 27, 2007 | Substantially Equivalent |
| K063307 | ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) | Feb 27, 2007 | Substantially Equivalent |
| K063320 | ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) | Feb 27, 2007 | Substantially Equivalent |
| K063203 | ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) | Feb 13, 2007 | Substantially Equivalent |
| K063475 | IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) | Jan 23, 2007 | Substantially Equivalent |
| K063474 | ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) | Dec 22, 2006 | Substantially Equivalent |
| K031897 | PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER | Sep 23, 2003 | Substantially Equivalent |
| K030432 | IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR | May 1, 2003 | Substantially Equivalent |
| K030427 | HP-3 HD ELECTRIC WHEELCHAIR | Apr 18, 2003 | Substantially Equivalent |