COMFORT ORTHOPEDIC CO., LTD.

Unified Business No.

66521706

Industry

Other Manufacturing (2,432)

Main products

Other transport equipment & parts n.e.c. (161)

Location

No. 120, Niuchoupu, Nanxiang Vil., Shuishang Township, Chiayi County 608008, Taiwan (R.O.C.)↗
Chiayi County (1,525) · Shuishang Township (222)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Lee Mao-shun

Phone

05-2890303

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Family-run (inferred)

North American market

FDA 510(k) clearance

Representative tenure

In office since 2022-02 (4 yrs); last handover 2022-02 (same surname)

Certifications 34

• Medical device license (188)Official registry Valid until 2015-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-08-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-08-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-10-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-11-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-04-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-12-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-03-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-01-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-03-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-05-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-06 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 12

• FDA 510(k) clearance K072711 2007-10-31
  COMFORT POWERED WHEELCHAIR, LY-EB 206
• FDA 510(k) clearance K072712 2007-10-31
  COMFORT ELECTRIC SCOOTER, LY-EW408
• FDA 510(k) clearance K063030 2006-12-04
  COMFORT SCOOTER MODEL LY-EW406
• FDA 510(k) clearance K063032 2006-10-16
  COMFORT SCOOTER, MODEL LY-EW415
• FDA 510(k) clearance K031621 2004-01-22
  HERO 1, MODEL LY-ESB220
• FDA 510(k) clearance K031618 2003-12-18
  COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
• FDA 510(k) clearance K030355 2003-05-20
  COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
• FDA 510(k) clearance K030356 2003-05-20
  COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
• FDA 510(k) clearance K023581 2002-12-02
  COMFORT AGILE SCOOTER, LY-EW303
• FDA 510(k) clearance K021910 2002-10-11
  COMFORT DREAMRIDER SCOOTER, LY-EW402
• FDA 510(k) clearance K022369 2002-10-11
  COMFORT WINDJOY SCOOTER, MODEL LY-EW302
• FDA 510(k) clearance K020451 2002-03-14
  COMFORT WHEELCHAIRS

Recent changes 5

• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-05-20
  Certification expiryMedical device license (Class II) certificate expired on 2026-05-20
• 2026-03-22
  Certification expiryMedical device license (Class I) certificate expired on 2026-03-22
• 2026-01-11
  Certification expiryMedical device license (Class II) certificate expired on 2026-01-11
• 2025-11-17
  Certification expiryMedical device license (Class I) certificate expired on 2025-11-17

RSS feed · Recent changes at Taiwanese manufacturers →

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