FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARD HOLDER FOR QUADS
K Number: K823657
·
Decision Jan 21, 1983
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
6
Applicant Total
278
Review Days
46
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Basic Information
- Device Name
- CARD HOLDER FOR QUADS
- K Number
- K823657
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- December 6, 1982
- Decision Date
- January 21, 1983
- Product Code
- ILT
- 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 |
|---|---|---|---|
| ILT | Adaptor, Recreational | FDA class 1 | Physical Medicine |
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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 |