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helavo H2320

by Helavo Corporation GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810225940018 UDI-DIDate1 Jul 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
helavo
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Reference
H2320
Primary DI / UDI-DI
00810225940018
510(k) Number
FDA Product Code
ITI
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled
Device Class
Class II
Regulation Number
890.3860
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K242471)

Other devices from Helavo Corporation

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No