FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACTION ACCESSORIES
K Number: K844490
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
9
Review Days
93
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Basic Information
- Device Name
- TRACTION ACCESSORIES
- K Number
- K844490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Jerome Medical
- Date Received
- November 20, 1984
- Decision Date
- February 21, 1985
- Product Code
- ILZ
- 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 |
|---|---|---|---|
| ILZ | Accessories, Traction | FDA class 1 | Physical Medicine |
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HEAD HALTER
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Other Clearances by Jerome Medical
| K Number | Device Name | ||
|---|---|---|---|
| K051918 | RESOLVE OPEN BACK HALO RINGS | Aug 17, 2005 | Substantially Equivalent |
| K930021 | J TONGS | Dec 6, 1995 | Substantially Equivalent |
| K930153 | SYSTEM III HALO RING | Aug 6, 1993 | Substantially Equivalent |
| K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE | Sep 30, 1988 | Substantially Equivalent |
| K870053 | TORQUEDRIVER WRENCH | Mar 11, 1987 | Substantially Equivalent |
| K864969 | JMS HALO APPLICATION TRAY | Feb 18, 1987 | Unknown |
| K822780 | CERVICAL BRACE | Oct 6, 1982 | Substantially Equivalent |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jun 10, 1982 | Substantially Equivalent |