FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇩🇪 Germany
THERMO SHORTWAVE DIATHERMY
K Number: K852166
·
Decision Sep 30, 1985
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
12
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THERMO SHORTWAVE DIATHERMY
- K Number
- K852166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Zimmer Elektromedizin GmbH
- Date Received
- May 20, 1985
- Decision Date
- September 30, 1985
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IMJ), ordered by most recent decision date.
BTL-899TT
FDA 510(k)
FDA Class 2
·Physical Medicine
ViVY
FDA 510(k)
FDA Class 2
·Physical Medicine
Curapuls 670
FDA 510(k)
FDA Class 2
·Physical Medicine
Reprieve by RegenesisTM
FDA 510(k)
FDA Class 2
·Physical Medicine
BTL-703
FDA 510(k)
FDA Class 2
·Physical Medicine
ViaTherm BOOST
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Zimmer Elektromedizin GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K080735 | CRYOMINI | Apr 4, 2008 | Substantially Equivalent |
| K060395 | CRYO, MODEL V6.0 | Feb 24, 2006 | Substantially Equivalent |
| 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 |
| K850006 | TENS | Dec 20, 1985 | Substantially Equivalent for Some Indications |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |