FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MP-3C POWER BASE CHAIR, MODEL MP3C
K Number: K011687
·
Decision Aug 3, 2001
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
12
Review Days
64
Basic Information
- Device Name
- MP-3C POWER BASE CHAIR, MODEL MP3C
- K Number
- K011687
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MERITS HEALTH PRODUCTS., INC.
- Date Received
- May 31, 2001
- Decision Date
- August 3, 2001
- 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 MERITS HEALTH PRODUCTS., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K012802 | MP3CF ELECTRIC WHEELCHAIR | Sep 18, 2001 | Substantially Equivalent |
| K011844 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Aug 28, 2001 | Substantially Equivalent |
| K011513 | MP3U, POWER WHEELCHAIR | Aug 10, 2001 | Substantially Equivalent |
| K011751 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 | Aug 6, 2001 | Substantially Equivalent |
| K011753 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 | Aug 3, 2001 | Substantially Equivalent |
| K010380 | MP3HD BIG BOY, POWER WHEELCHAIR | May 9, 2001 | Substantially Equivalent |
| K003815 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER | Dec 27, 2000 | Substantially Equivalent |
| K993032 | MODIFICATION TO MP-3 POWER BASE CHAIR | Nov 5, 1999 | Substantially Equivalent |
| K982066 | MP-3 POWER BASE CHAIR | Aug 31, 1998 | Substantially Equivalent |
| K933662 | MERITS WHEELCHAIR | Mar 30, 1994 | Substantially Equivalent for Some Indications |