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JAS Pulse 64-405-0003

by Axiosonic, LLC

JAS Pulse 64-405-0003 is a Class II device made by Axiosonic, LLC, cleared under FDA 510(k) K161628 on 10 Nov 2016 and listed in FDA GUDID since 21 Dec 2017 (UDI-DI 00861681000303), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K161628

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00861681000303 UDI-DI Date21 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK161628 Date10 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161628 decided 10 Nov 2016 Active
  • FDA GUDID UDI-DI 00861681000303 listed 21 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161628
  2. Listed FDA GUDID 00861681000303

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
JAS Pulse
Generic name
Physical therapy ultrasound system
Model / reference
64-405-0003
Primary DI / UDI-DI
00861681000303
510(k) Number
FDA product code
IMI
GMDN term
Physical therapy ultrasound system
Device class
Class II
Regulation number
890.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy ultrasound system

Cleared under the same submission (K161628)

Similar devices

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

Other devices from Axiosonic, LLC

Properties

  • Prescription use
Other properties (14, all answered No)