FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K Number: K813636
·
Decision Jan 19, 1982
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
278
Review Days
21
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Basic Information
- Device Name
- BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
- K Number
- K813636
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- December 29, 1981
- Decision Date
- January 19, 1982
- Product Code
- KNN
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
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Other Clearances by Fred Sammons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 | Substantially Equivalent |
| K831550 | FINGER BONIOMETER BK7506 | Jun 24, 1983 | Substantially Equivalent |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Jun 24, 1983 | Substantially Equivalent |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Jun 16, 1983 | Substantially Equivalent |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Jun 8, 1983 | Substantially Equivalent |