Stellar LEAP

510(k) Number

K163432 ↗

FDA product code

IOR

FDA applicant

Pdg Product Design Group, Inc.

Device class

Class I

Regulation

21 CFR Part 890.3850

Advisory committee

Physical Medicine

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IOR (Wheelchair, Mechanical).

• Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) by ANHUI JBH MEDICAL APPARATUS CO., LTD
• POIRIER KID-ROLLER MANUAL WHEELCHAIR by Roseburg SA
• Flexx Junior (FLX-J00, FLX-J50) by Karma Mobility Co, Ltd.
• KAIYANG STEEL WHEELCHAIR by Guangdong Kaiyang Medical Technology Co., Ltd.
• COMPETITOR by Kuschall of America
• MYCYCLE, HANDMASTER, VICTORY by Richvale, Ltd.
• CHUMP by Colours 'N Motion
• E Z CHAIR by Premier Designs
• MUSTANG by Temco, Inc.
• Nuocande Plastic Manual Wheelchair Model NKD L07 by Ningbo Lecount Medical Technology Co., Ltd.

• Stellar Manual Tilt Wheelchair STELLAR HD

  Class I

  CE/MDR FDA 510(k) K990557 Active Cleared 22 Mar 1999 +1authorizations

• Eclipse Bariatric Manual Wheelchair

  Class I

  CE/MDR FDA 510(k) K971389 Active Cleared 9 May 1997 +1authorizations

• Stellar Manual Tilt Wheelchair STELLAR IMPACT

  Class I

  CE/MDR FDA 510(k) K990557 Active Cleared 22 Mar 1999 +1authorizations

• Bentley Manual Tilt Wheelchair BENTLEY LT

  Class I

  CE/MDR FDA 510(k) K970311 Active Cleared 14 Feb 1997 +1authorizations

See all devices from PDG Product Design Group Inc →