FDA 510(k)
Substantially Equivalent for Some Indications
🇳🇱 Netherlands
PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI
K Number: K850872
·
Decision Jun 6, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
97
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Basic Information
- Device Name
- PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI
- K Number
- K850872
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Ketronic, Inc.
- Date Received
- March 1, 1985
- Decision Date
- June 6, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Other Clearances by Ketronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850877 | MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR | Jun 12, 1985 | Substantially Equivalent |
| K850873 | HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL | Jun 12, 1985 | Substantially Equivalent |
| K850870 | MEDIFETTE ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850868 | MFE CARDIAC STRESS SYSTEM | Jun 12, 1985 | Substantially Equivalent |
| K850869 | MFE COUCH ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | Jun 5, 1985 | Substantially Equivalent |
| K850876 | LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR | May 16, 1985 | Substantially Equivalent |
| K850875 | ACTION-WHEELS & PLAY WHEELS | May 16, 1985 | Substantially Equivalent |
| K843288 | KETRONIC MEDAX - N | Nov 8, 1984 | Substantially Equivalent |