FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K Number: K024036
·
Decision Dec 20, 2002
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
7
Review Days
14
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
- PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
- K Number
- K024036
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johari Digital Healthcare , Ltd.
- Date Received
- December 6, 2002
- Decision Date
- December 20, 2002
- 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 Johari Digital Healthcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K131291 | TORC BODY | Jun 14, 2013 | Substantially Equivalent |
| K112351 | ULTRA BEAUTY | Mar 30, 2012 | Substantially Equivalent |
| K102190 | WINSTIM | Mar 17, 2011 | Substantially Equivalent |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | May 29, 2009 | Substantially Equivalent |
| K062439 | POWERTONE, MODEL PT-11 | Jan 8, 2007 | Substantially Equivalent |
| K060246 | INFREX | May 5, 2006 | Substantially Equivalent |