FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇨🇦 Canada
ULTRA IV
K Number: K960489
·
Decision Mar 27, 1996
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
58
Review Days
54
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
- ULTRA IV
- K Number
- K960489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Excel Tech. , Ltd.
- Date Received
- February 2, 1996
- Decision Date
- March 27, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPF), ordered by most recent decision date.
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·Physical Medicine
High Tone Power therapy (HiToP) (Model: HiToP PNP)
FDA 510(k)
FDA Class 2
·Physical Medicine
StimelMD (SSMD) system
FDA 510(k)
FDA Class 2
·Physical Medicine
Compact II
FDA 510(k)
FDA Class 2
·Physical Medicine
EVE Synergy (EVE-20M)
FDA 510(k)
FDA Class 2
·Physical Medicine
TrainFES Advance
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Excel Tech. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | Oct 4, 2006 | Substantially Equivalent |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | Aug 14, 2006 | Substantially Equivalent |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | Apr 21, 2006 | Substantially Equivalent |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Feb 7, 2006 | Substantially Equivalent |
| 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 |