FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SORBOTHANE VISCO INNER SOLE PAD
K Number: K831552
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
203
Registration Numbers
203
Same Product Code
6
Applicant Total
278
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SORBOTHANE VISCO INNER SOLE PAD
- K Number
- K831552
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- May 12, 1983
- Decision Date
- June 8, 1983
- Product Code
- KNP
- 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 |
|---|---|---|---|
| KNP | Orthosis, Corrective Shoe | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNP), ordered by most recent decision date.
IPOS ANTI-ADDUCTUS SHOE
FDA 510(k)
FDA Class 1
·Physical Medicine
SLIP-ON SANDALS FOR MEASURING SHORTNESS
FDA 510(k)
FDA Class 1
·Physical Medicine
ROTATION BOOT
FDA 510(k)
FDA Class 1
·Physical Medicine
SORBOTHANE
FDA 510(k)
FDA Class 1
·Physical Medicine
PLASTAZOTE SHOE
FDA 510(k)
FDA Class 1
·Physical Medicine
DRUSHOE
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Fred Sammons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | May 6, 1988 | Substantially Equivalent |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Apr 1, 1988 | Substantially Equivalent |
| K831549 | ARM SLINGS | Jun 30, 1983 | Substantially Equivalent |
| K831548 | SPLINTS | Jun 27, 1983 | Substantially Equivalent |
| 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 |