510(k) Report

FDA applicant

Johari Digital Healthcare, Ltd.

Jodhpur, IN10 decisions2002–20230 recalls

FDA records 10 decisions for Johari Digital Healthcare, Ltd. (Jodhpur, IN) from 2002 to 2023: 10 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and NFO (Stimulator, Transcutaneous Electrical…). Since 2016 its 510(k)s took a median of 451 days from receipt to decision, against 207 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Johari Digital Healthcare Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Johari Digital Healthcare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12009: 12011: 12012: 12013: 12020: 12022: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Johari Digital Healthcare, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Johari Digital Healthcare, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Johari”

FDA records each applicant name separately; these may or may not be the same firm.