FDA 510(k)
Substantially Equivalent for Some Indications
🇩🇪 Germany
TENS
K Number: K850006
·
Decision Dec 20, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
352
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Basic Information
- Device Name
- TENS
- K Number
- K850006
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Zimmer Elektromedizin GmbH
- Date Received
- January 2, 1985
- Decision Date
- December 20, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
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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 |
| K954411 | GALVA-5-M | Feb 28, 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 |
| K852166 | THERMO SHORTWAVE DIATHERMY | Sep 30, 1985 | Substantially Equivalent for Some Indications |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |