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FDA product code · Physical Medicine · Class 2

NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

NGX is FDA's product code for "Stimulator, Muscle, Powered, For Muscle Conditioning": a Class 2 device classified under 21 CFR 890.5850, reviewed by the Physical Medicine panel.

510(k) review time for NGX

Across 92 510(k) clearances under NGX decided from 2018-01-01 to 2026-10-06, the median was 164 days from FDA receipt to decision. Half took between 87 and 269 days, and 80% were decided within 295 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NGX, decisions 2018-01-01 to 2026-10-06 (n = 92)
Fastest13
25th percentile87
Median164
75th percentile269
80th percentile295
90th percentile404
Slowest783
Median days by decision year, NGX (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181046
201916714
202020711
202125612
20223076
20239612
202420712
20259315

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

NGX in the public FDA record

Records naming NGX, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years163
Establishment listings466
GUDID device identifiers1,086

Counts of records, not of devices or events. Adverse event reports for NGX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite NGX

2 FDA recognized consensus standards cite NGX, among them IEC 60601-2-10 Edition 2.1 2016-04; IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 17-16 IEC 60601-2-10 Edition 2.1 2016-04 — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
  • 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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