FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISTRAC(TM) TABLE
K Number: K900475
·
Decision May 24, 1990
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
8
Review Days
112
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Basic Information
- Device Name
- DISTRAC(TM) TABLE
- K Number
- K900475
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Lossing Orthopedic, Inc.
- Date Received
- February 1, 1990
- Decision Date
- May 24, 1990
- Product Code
- ITH
- 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 |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Lossing Orthopedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864152 | BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE | Feb 5, 1987 | Substantially Equivalent |
| K862874 | THE TOWERED 90/90 UNIT | Aug 7, 1986 | Substantially Equivalent |
| K843581 | PROM NAID | Dec 11, 1984 | Substantially Equivalent |
| K840551 | MOBILIZER | Mar 23, 1984 | Substantially Equivalent |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | Jan 21, 1983 | Substantially Equivalent |
| K813017 | NECKTRAC | Nov 25, 1981 | Substantially Equivalent |
| K802555 | COTTRELL 90/90 BACKTRAC | Oct 31, 1980 | Substantially Equivalent |