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Roovjoy R-E1

by Shenzhen roundwhale technology co. LTD.

Roovjoy R-E1 is a Class II device made by Shenzhen roundwhale technology co. LTD., cleared under FDA 510(k) K180956 on 7 Jun 2018 and listed in FDA GUDID since 16 Jul 2018 (UDI-DI 00840001700031), active as of 23 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 23 Oct 2026

Documents

510(k) K180956

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840001700031 UDI-DI Date16 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180956 Date7 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180956 decided 7 Jun 2018 Active
  • FDA GUDID UDI-DI 00840001700031 listed 16 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180956
  2. Listed FDA GUDID 00840001700031

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Roovjoy
Generic name
Transcutaneous electrical stimulation probe
Model / reference
R-E1
Primary DI / UDI-DI
00840001700031
510(k) Number
FDA product code
NGX
GMDN term
Transcutaneous electrical stimulation probe
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemTranscutaneous electrical stimulation probe

Cleared under the same submission (K180956)

and 2 more cleared under K180956

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Shenzhen roundwhale technology co. LTD.

See all devices from Shenzhen roundwhale technology co. LTD. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)