Data / Medical devices / India / Syrma Johari MedTech Limited
Syrma Johari MedTech Limited: FDA-registered device maker in Jodhpur Rajasthan, India, 18 510(k) clearances
Syrma Johari MedTech Limited is registered with the FDA (registration 8040537) in Jodhpur Rajasthan, India. It lists 20 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 27, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8040537
- FEI number
- 3005154439
- Address
- G-582-584, EPIP, Boranada 342012, Jodhpur (Rajasthan), Jodhpur Rajasthan, India, 342012
- Owner or operator
- Syrma JoharI MedTech Limited (10023876)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 19, 2007
- Registered through
- 2026
- Brand names listed
- AP439, All Stim, All Stim (Mini), Bio Med Fit, EPR (Electronic Pain Reliever), FM 10/C, FM 10/C (CRANIAL ELECTRICAL NERVE STIMULATOR), HILL IFC Interferential Unit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2023 | K213078 | Myolift QT | NFO | Substantially Equivalent | Johari Digital Healthcare Limited | accessdata.fda.gov |
| December 3, 2022 | K212866 | truSculpt flex | NGX | Substantially Equivalent | Johari Digital Healthcare Limited | accessdata.fda.gov |
| March 29, 2020 | K192039 | Torc Body | NGX | Substantially Equivalent | Johari Digital Healthcare Limited | accessdata.fda.gov |
| April 17, 2019 | K183634 | Stasis Monitoring System | MWI | Substantially Equivalent | Stasis Labs, Inc. | accessdata.fda.gov |
| April 24, 2014 | K132563 | PINOOK STIMULATOR | NUH | Substantially Equivalent | Pinook USA | accessdata.fda.gov |
| June 14, 2013 | K131291 | TORC BODY | NGX | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| March 30, 2012 | K112351 | ULTRA BEAUTY | NFO | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| March 17, 2011 | K102190 | WINSTIM | IMG | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| May 29, 2009 | K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | QJQ | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| July 30, 2008 | K073386 | JOINT STIM, MODEL 1000 | NYN | Substantially Equivalent | Pain Management Technologies | accessdata.fda.gov |
| March 12, 2008 | K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL | PFW | Substantially Equivalent | Hill Laboratories Co. | accessdata.fda.gov |
| January 8, 2007 | K062439 | POWERTONE, MODEL PT-11 | NGX | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| May 30, 2003 | K031017 | SYS*STIM 208 AND 208A | IPF | Substantially Equivalent | Mettler Electronics Corp. | accessdata.fda.gov |
| December 20, 2002 | K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | IPF | Substantially Equivalent | Johari Digital Healthcare , Ltd. | accessdata.fda.gov |
| February 5, 2001 | K993600 | MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 | LIH | Substantially Equivalent | Nisha Communication Industries | accessdata.fda.gov |
| February 2, 2001 | K993229 | ANALGESIC PULSER, MODEL AP-439 | GZJ | Substantially Equivalent | Johari Electro-Tech Co. | accessdata.fda.gov |
| July 13, 1998 | K980040 | ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D | IPF | Substantially Equivalent | Nisha Communication Industries | accessdata.fda.gov |
| October 24, 1989 | K883811 | ELECTRONIC PAIN RELIEVERS | GZJ | Substantially Equivalent | Jetco of America | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Interferential Current Therapy
- All makers of Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Updated April 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.