FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GUO GUANG WHEEL CHAIR
K Number: K870043
·
Decision Jan 28, 1987
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
12
Review Days
23
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Basic Information
- Device Name
- GUO GUANG WHEEL CHAIR
- K Number
- K870043
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- China National Medicines & Health Prod. I/E Corp.
- Date Received
- January 5, 1987
- Decision Date
- January 28, 1987
- 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 China National Medicines & Health Prod. I/E Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K902324 | TP AND DESIGN, CONDOM | Mar 29, 1991 | Substantially Equivalent |
| K893351 | LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) | Nov 17, 1989 | Substantially Equivalent |
| K892916 | PATIENT EXAMINATION GLOVES (LATEX) | Jul 14, 1989 | Substantially Equivalent |
| K891365 | LATEX EXAMINATION GLOVES, NON-STERILE | Apr 26, 1989 | Substantially Equivalent |
| K870306 | WHITE PLUME TRIANGULAR BANDAGE | Feb 24, 1987 | Substantially Equivalent |
| K870309 | WHITE PLUME ABSORBENT COTTON WOOL | Feb 24, 1987 | Substantially Equivalent |
| K870312 | WHITE PLUME SURGICAL GAUZE FACE MASK | Feb 24, 1987 | Substantially Equivalent |
| K870308 | WHITE PLUME ABSORBENT GAUZE | Feb 24, 1987 | Substantially Equivalent |
| K870315 | WHITE PLUME ABSORBENT BANDAGE | Feb 24, 1987 | Substantially Equivalent |
| K870314 | WHITE PLUME GAUZE SPONGE | Feb 24, 1987 | Substantially Equivalent |