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EnsoTherapy 6.0

by Ensodata, Inc.

EnsoTherapy 6.0 is a Class I device made by Ensodata, Inc., listed in FDA GUDID since 20 Nov 2023 (UDI-DI 00864458000421), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864458000421 UDI-DI Date20 Nov 2023ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
EnsoTherapy
Generic name
Vulnerable patient home-monitoring software, professional-only
Model / reference
6.0
Primary DI / UDI-DI
00864458000421
FDA product code
OUG
GMDN term
Vulnerable patient home-monitoring software, professional-only
Device class
Class I
Regulation number
880.6310
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Vulnerable patient home-monitoring software, professional-only

Similar devices

Other devices filed under FDA product code OUG (Medical Device Data System).

Other devices from Ensodata, Inc.

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    Class II

  • EnsoSleep 8

    Class II

  • EnsoSleep PPG 8

    Class II

  • EnsoSleep

    Class II

See all devices from Ensodata, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)