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Stimulation System PR38

by Edan Instruments, Inc.

Stimulation System PR38 is a Class II device made by Edan Instruments, Inc., cleared under FDA 510(k) K232786 on 16 May 2024 and listed in FDA GUDID since 15 May 2026 (UDI-DI 06944413866140), 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) K232786

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 Number06944413866140 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232786 Date16 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232786 decided 16 May 2024 Active
  • FDA GUDID UDI-DI 06944413866140 listed 15 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232786
  2. Listed FDA GUDID 06944413866140

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stimulation System
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
PR38
Primary DI / UDI-DI
06944413866140
510(k) Number
FDA product code
IPF, GZJ
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850, 882.5890
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K232786)

and 8 more cleared under K232786

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)