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Impulse 4000T KIM4T

by BioMedical Life Systems Inc.

Impulse 4000T KIM4T is a medical device (FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief) made by BioMedical Life Systems Inc., cleared under FDA 510(k) K073438 on 7 Feb 2008 and listed in FDA GUDID since 27 Dec 2018 (UDI-DI 00857771003989), 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) K073438

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 Number00857771003989 UDI-DI Date27 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073438 Date7 Feb 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073438 decided 7 Feb 2008 Active
  • FDA GUDID UDI-DI 00857771003989 listed 27 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073438
  2. Listed FDA GUDID 00857771003989

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Impulse 4000T
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Model / Ref / Catalog
KIM4T
Primary DI / UDI-DI
00857771003989
510(k) Number
FDA product code
GZJ
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)