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Sonopuls 190

by Enraf-Nonius B.V.

510(k) K230472

Sonopuls 190 is a Class II device made by Enraf-Nonius B.V., cleared under FDA 510(k) K230472 on 24 Oct 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230472 Date24 Oct 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IMI
FDA applicant
Enraf-Nonius, B.V.
Device class
Class II
Regulation
21 CFR Part 890.5300
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K230472

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K230472
UDI-DISize and differences
Sonopuls 190 1631940
Enraf-Nonius B.V.
163194008720618311221 —On the market
Sonopuls 190 1631951
Enraf-Nonius B.V.
163195108720618311108 —On the market

Similar devices

Other devices filed under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat).

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