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ZIP’r Mantis 01

by Global Fabtech (Shanghai) Co., Ltd. 4 variants

ZIP’r Mantis 01 is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Global Fabtech (Shanghai) Co., Ltd., cleared under FDA 510(k) K102355 on 4 Oct 2010 and listed in FDA GUDID since 24 Sep 2023 (UDI-DI 06972356130202), 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) K102355

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 Number06972356130202 UDI-DI Date24 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102355 Date4 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102355 decided 4 Oct 2010 Active
  • FDA GUDID UDI-DI 06972356130202 listed 24 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102355
  2. Listed FDA GUDID 06972356130202

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ZIP’r Mantis
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Model / reference
01
Primary DI / UDI-DI
06972356130202
510(k) Number
FDA product code
ITI
GMDN term
Electric-motor-driven wheelchair, occupant-controlled
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.

Other devices from Global Fabtech (Shanghai) Co., Ltd.

  • Zip'r 4 01

    Class II
  • ZIP’r Mantis 01

    Class II
  • ZIP’r 3 01

    Class II
  • ZIP’r PC 01

    Class II

See all devices from Global Fabtech (Shanghai) Co., Ltd. →

Properties

  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)