FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇩🇪 Germany
GALVA-5-M
K Number: K954411
·
Decision Feb 28, 1996
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
12
Review Days
160
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Basic Information
- Device Name
- GALVA-5-M
- K Number
- K954411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Zimmer Elektromedizin GmbH
- Date Received
- September 21, 1995
- Decision Date
- February 28, 1996
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K040727 | CRYO 5 | Apr 23, 2004 | Substantially Equivalent |
| K960969 | GALVA 5-T | May 15, 1996 | Substantially Equivalent |
| K952536 | SONO 5 | Mar 5, 1996 | Substantially Equivalent for Some Indications |
| K924473 | DISPOSABLE THERAPY ELECTRODE | May 19, 1993 | Substantially Equivalent |
| K860758 | VACO SUCTION ELECTRODE UNIT | May 2, 1986 | Substantially Equivalent |
| K850006 | TENS | Dec 20, 1985 | Substantially Equivalent for Some Indications |
| K852166 | THERMO SHORTWAVE DIATHERMY | Sep 30, 1985 | Substantially Equivalent for Some Indications |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |