FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EXCEL STIM
K Number: K896836
·
Decision Feb 20, 1990
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
58
Review Days
99
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Basic Information
- Device Name
- EXCEL STIM
- K Number
- K896836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Excel Tech. , Ltd.
- Date Received
- November 13, 1989
- Decision Date
- February 20, 1990
- 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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| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Oct 28, 2005 | Substantially Equivalent |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | Aug 17, 2005 | Substantially Equivalent |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | Sep 16, 2004 | Substantially Equivalent |
| K042150 | XLTEK TREX MODEL#10309 | Aug 27, 2004 | Substantially Equivalent |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | Aug 6, 2004 | Substantially Equivalent |
| K040360 | EMU128S, MODEL EX-NW-128S | Mar 12, 2004 | Substantially Equivalent |