UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)

Wheelchair, Mechanical

ASSEMBLY REQUIRED DIST., INC.

The following data is part of a premarket notification filed by Assembly Required Dist., Inc. with the FDA for Universal/1000 Series(101s101sdu1100)/rolls 2000(2000e)/transport(m4).

Pre-market Notification Details

• Device ID: K973418
• 510k Number: K973418
• Device Name: UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
• Classification: Wheelchair, Mechanical
• Applicant: ASSEMBLY REQUIRED DIST., INC. 3 CRABAPPLE LN. Commack, NY 11725 -2403
• Contact: Robert J Murphy
• Correspondent: Robert J Murphy; ASSEMBLY REQUIRED DIST., INC. 3 CRABAPPLE LN. Commack, NY 11725 -2403
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-10
• Decision Date: 1997-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860004575610	K973418	000
00854204008061	K973418	000
00854204008078	K973418	000
00854204008085	K973418	000
00854204008092	K973418	000
00854204008108	K973418	000
00854204008115	K973418	000
00854204008122	K973418	000
00854204008139	K973418	000
00854204008405	K973418	000
00854204008054	K973418	000
00853301008097	K973418	000
00854362008439	K973418	000
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00853301008011	K973418	000
00853301008042	K973418	000
00853301008059	K973418	000
00853301008066	K973418	000
00853301008073	K973418	000
00853301008080	K973418	000
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00854362008408	K973418	000
00863574000438	K973418	000
00863574000469	K973418	000
00863574000476	K973418	000
00863574000483	K973418	000
00863574000490	K973418	000
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00854362008316	K973418	000
00854362008323	K973418	000
00854362008330	K973418	000
00854362008347	K973418	000
00865388000475	K973418	000