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Epulse Pro 1200

by Shenzhen Jiantuo Electronics Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06978452680023 UDI-DI Date1 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Epulse
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference
PRO 1200
Primary DI / UDI-DI
06978452680023
510(k) Number
FDA Product Code
NUH, NGX
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
882.5890, 890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250360)

Other devices from Shenzhen Jiantuo Electronics Co., Ltd.

See all devices from Shenzhen Jiantuo Electronics Co., Ltd. →

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No