FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NECKTRAC
K Number: K813017
·
Decision Nov 25, 1981
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- NECKTRAC
- K Number
- K813017
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Lossing Orthopedic, Inc.
- Date Received
- October 27, 1981
- Decision Date
- November 25, 1981
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Lossing Orthopedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900475 | DISTRAC(TM) TABLE | May 24, 1990 | Substantially Equivalent |
| 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 |
| K802555 | COTTRELL 90/90 BACKTRAC | Oct 31, 1980 | Substantially Equivalent |