FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRUNCAL ORTHOSIS
K Number: K810450
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
323
Registration Numbers
323
Same Product Code
3
Applicant Total
278
Review Days
13
Basic Information
- Device Name
- TRUNCAL ORTHOSIS
- K Number
- K810450
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- February 19, 1981
- Decision Date
- March 4, 1981
- Product Code
- IQE
- 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 |
|---|---|---|---|
| IQE | Orthosis, Lumbar | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IQE), ordered by most recent decision date.
TRUNCAL ORTHOSIS
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OBUS FORME ORTHOPEDIC BRACE, UPRIGHT
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FDA Class 1
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PROSANA BELT
FDA 510(k)
FDA Class 1
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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 |