FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
745-M (MAGNUM)
K Number: K922980
·
Decision Jul 13, 1992
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
65
Applicant Total
35
Review Days
21
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Basic Information
- Device Name
- 745-M (MAGNUM)
- K Number
- K922980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tri W-G, Inc.
- Date Received
- June 22, 1992
- Decision Date
- July 13, 1992
- Product Code
- JFB
- 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 |
|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
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Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
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Other Clearances by Tri W-G, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960196 | TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 | Feb 7, 1996 | Substantially Equivalent |
| K945163 | ECHOCARDIOGRAPHY | Feb 17, 1995 | Substantially Equivalent |
| K941720 | MODEL 747 AND 747-30 EXAM/TREATMENT TABLE | May 6, 1994 | Substantially Equivalent |
| K936303 | TREATMENT TABLE MODIFICATION | Mar 18, 1994 | Substantially Equivalent |
| K933119 | HI-LO TREATMENT TABLES | Oct 12, 1993 | Substantially Equivalent |
| K932746 | MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE | Jul 21, 1993 | Substantially Equivalent |
| K930802 | MODELS 642 & 643 TILT EXAM/TREATMENT TABLE | Mar 22, 1993 | Substantially Equivalent |
| K925594 | MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE | Feb 12, 1993 | Substantially Equivalent |
| K923325 | MODEL 600 MEDICAL TREATMENT TABLE | Jul 21, 1992 | Substantially Equivalent |
| K920585 | MAT TABLE, 8100 SERIES MAT PLATFORM | Apr 7, 1992 | Substantially Equivalent |