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SOLAX

by Dongguan Prestige Sporting Goods Co., Ltd.

510(k) K131302

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131302 Date26 Nov 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
INI
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a motorized 3-wheeled vehicle classified under device class 2. It is identified by the product code INI and regulation number 890.3800.

It received FDA 510(k) clearance (K131302) on November 26, 2013, as substantially equivalent to a predicate device. The device is authorized for use in physical medicine settings.

Other devices from Dongguan Prestige Sporting Goods Co., Ltd.

See all devices from Dongguan Prestige Sporting Goods Co., Ltd. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SOLAX device intended for?

    The SOLAX is a motorized 3-wheeled vehicle authorized for use in physical medicine settings, as indicated by its FDA 510(k) clearance and classification under product code INI and regulation 890.3800, which pertains to devices used in physical medicine applications.

  • How was the SOLAX device cleared for market release?

    The SOLAX received FDA 510(k) clearance (K131302) on November 26, 2013, as substantially equivalent to a predicate device, following a traditional review process under device class 2, with no requirement for clinical trials beyond demonstrating substantial equivalence.

  • What regulatory identifiers are associated with the SOLAX device?

    The SOLAX is identified by the product code INI, regulation number 890.3800, device name SOLAX, and k-number K131302, with its clearance linked to the applicant Dongguan Prestige Sporting Goods Co., Ltd. and FEI numbers listed in the OpenFDA data.