510(k) K031618
- Device
- COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
- Applicant
- COMFORT ORTHOPEDIC CO. LTD.
- 510(k) number
- K031618
- Product code
- IPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-18
- Date received
- 2003-05-23
- Regulation
- 890.3900
- Classification name
- Wheelchair, Standup
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC H.C. LEE
- Address
- # 120 Nan Shiang Tsuen, Shoei Shang Shiang Chia-Yi TW
FDA Registration Numbers#
- 3023852281
- 1221084
- 3007494904
- 9681680
- 3014653196
- 8030931
- 3010585416
- 3003650116
- 9615350
- 3014250398
- 2937137
- 3007923118
- 3022115583
- 3019677893
- 3014890685
- 9681725
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243783 | Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. | 2025-03-12 |
| K202728 | Action Trackchair Hawk | Action Manufacturing, Inc. | 2022-02-10 |
| K203761 | ParaMotion | Powerbasetec GmbH | 2022-01-21 |
| K191334 | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | Matia Robotics (Us), Inc. | 2020-05-29 |
| K190682 | Explorer Mini | Permobil AB | 2020-02-27 |
| K191874 | F5 Corpus VS | Permobil AB | 2019-10-25 |
| K182257 | UPnRIDE | Upnride Robotics , Ltd. | 2019-09-12 |
| K191376 | Modular Power Standing System | Motion Concepts | 2019-08-13 |
| K172384 | Quickie(r) Q700-UP M | Sunrise Medical (Us), LLC | 2018-01-16 |
| K163451 | Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | Action Manufacturing, Inc. | 2018-01-12 |
| K150548 | Tek RMD (Tek Robotic Mobilization Device) | Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S | 2015-06-11 |
| K122562 | E-TENG MODEL EOR 1 | E-Teng Technology, Inc. | 2013-08-09 |
| K102837 | HIROLLER ELEVATING WHEELCHAIR | Max Mobility, LLC | 2010-12-23 |
| K102734 | COMFORT STANDING WHEELCHAIR, HERO SERIES | Comfort Orthopedic Co., Ltd. | 2010-12-14 |
| K090256 | POWER STANDING DANI | Davismade, Inc. | 2009-07-06 |
Legacy Summary#
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FDA Review#
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