21ST CENTURY SCIENTIFIC, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2027797	1000125727	21ST CENTURY SCIENTIFIC, INC.	1	N	2026-01-01	4931 N Manufacturing Way Coeur D Alene ID US 83815

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
72473	1321271643	K954044	SIDEKICK POWER WHEELCHAIR	ITI	1995-10-13
72473	2014122827	K901210	BOUNDER VA POWER WHEELCHAIR	ITI	1990-03-26
72473	1072965819	K193599	BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair	ITI	2020-09-03
72473	1502984728
72473	1757430210

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
ITI	3	2020-09-03

PMN#

BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
2020-09-03
21st Century Scientific, Inc.
SIDEKICK POWER WHEELCHAIR
1995-10-13
21ST CENTURY SCIENTIFIC, INC.
BOUNDER VA POWER WHEELCHAIR
1990-03-26
21ST CENTURY SCIENTIFIC, INC.

GUDID#

Bounder - BOUNDER PLUS
21ST CENTURY SCIENTIFIC, INC.
2017-07-05
Bounder - BIG BOUNDER
21ST CENTURY SCIENTIFIC, INC.
2017-07-05
BOUNDER Plus - Power Gurney
21ST CENTURY SCIENTIFIC, INC.
2023-06-12
BOUNDER Plus - Manual Gurney
21ST CENTURY SCIENTIFIC, INC.
2023-06-11
BOUNDER - BOUNDER 300
21ST CENTURY SCIENTIFIC, INC.
2020-09-24
BOUNDER - BOUNDER PLUS 300
21ST CENTURY SCIENTIFIC, INC.
2020-09-24
BOUNDER - BOUNDER 450
21ST CENTURY SCIENTIFIC, INC.
2020-09-24
BOUNDER - BIG BOUNDER 600
21ST CENTURY SCIENTIFIC, INC.
2020-09-24
BOUNDER - BIG BOUNDER 1000
21ST CENTURY SCIENTIFIC, INC.
2020-09-24
Bounder - BOUNDER 300M
21ST CENTURY SCIENTIFIC, INC.
2018-08-14