ZHENJIANG ASURE MECHANICAL WHEELCHAIR

Wheelchair, Mechanical

ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD

The following data is part of a premarket notification filed by Zhenjiang Assure Medical Equipment Co., Ltd with the FDA for Zhenjiang Asure Mechanical Wheelchair.

Pre-market Notification Details

• Device ID: K112816
• 510k Number: K112816
• Device Name: ZHENJIANG ASURE MECHANICAL WHEELCHAIR
• Classification: Wheelchair, Mechanical
• Applicant: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD NO. FU CHIUN STREET Hsin Chu City, TW 30067
• Contact: Jen Ke-min
• Correspondent: Jen Ke-min; ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD NO. FU CHIUN STREET Hsin Chu City, TW 30067
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-28
• Decision Date: 2012-04-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841447116301	K112816	000
00810058401601	K112816	000
00810058401618	K112816	000
00860011289258	K112816	000
00860011289265	K112816	000
00860011289272	K112816	000
00860011289289	K112816	000
06974231101260	K112816	000
06974231101277	K112816	000
06974231101284	K112816	000
00841447116417	K112816	000
00841447116400	K112816	000
00841447116318	K112816	000
00841447116325	K112816	000
00841447116332	K112816	000
00841447116349	K112816	000
00841447116356	K112816	000
00841447116363	K112816	000
00841447116370	K112816	000
00841447116387	K112816	000
00841447116394	K112816	000
06974231101291	K112816	000
00815067012763	K112816	000
00815067079988	K112816	000
00815067079995	K112816	000
00815067070763	K112816	000
00815067070770	K112816	000
00815067070794	K112816	000
00815067070800	K112816	000
00815067078523	K112816	000
00815067078530	K112816	000
00815067078561	K112816	000
00815067079971	K112816	000
00815067079964	K112816	000
00815067012770	K112816	000
00815067012787	K112816	000
00815067012794	K112816	000
00815067012800	K112816	000
00815067012817	K112816	000
00815067012572	K112816	000
00815067012589	K112816	000
00815067079940	K112816	000
00815067079957	K112816	000
00815067080335	K112816	000