FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAISED CHAIR W/FOOT PLATFORM
K Number: K812347
·
Decision Sep 11, 1981
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
25
Applicant Total
278
Review Days
24
Basic Information
- Device Name
- RAISED CHAIR W/FOOT PLATFORM
- K Number
- K812347
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- FRED SAMMONS, INC.
- Date Received
- August 18, 1981
- Decision Date
- September 11, 1981
- Product Code
- INN
- 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 |
|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | FDA class 1 | Physical Medicine |
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| K Number | Device Name | ||
|---|---|---|---|
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| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 | Substantially Equivalent |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Jun 24, 1983 | Substantially Equivalent |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Jun 16, 1983 | Substantially Equivalent |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Jun 8, 1983 | Substantially Equivalent |