Johari Digital Healthcare , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Johari Digital Healthcare , Ltd.” (first 2002, latest 2013), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 227 |
| 2013 | 1 | 39 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 1 | 1 |
Review panels
- Physical Medicine (4)
- Neurology (3)
Most recent Johari Digital Healthcare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131291 | TORC BODY | NGX | 2013-06-14 | 39 |
| K112351 | ULTRA BEAUTY | NFO | 2012-03-30 | 227 |
| K102190 | WINSTIM | IMG | 2011-03-17 | 226 |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | QJQ | 2009-05-29 | 142 |
| K062439 | POWERTONE, MODEL PT-11 | NGX | 2007-01-08 | 140 |
| K060246 | INFREX | GZJ | 2006-05-05 | 94 |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | IPF | 2002-12-20 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Johari Digital Healthcare , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Johari Digital Healthcare Limited (3 510(k)s)
- Johari Electro-Tech Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johari Digital Healthcare , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Johari Digital Healthcare , Ltd.” (first 2002, latest 2013), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Johari Digital Healthcare , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johari Digital Healthcare , Ltd. is 140 days.
Which FDA product codes appear under Johari Digital Healthcare , Ltd.?
The most frequent FDA product codes under this applicant name are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 2); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 1).
Next steps
- See all 7 Johari Digital Healthcare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGX, Johari Digital Healthcare , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.