The following data is part of a premarket notification filed by The Standing Co., Inc. with the FDA for Superstand Stand-up Whellchair.
Device ID | K962278 |
510k Number | K962278 |
Device Name: | SUPERSTAND STAND-UP WHELLCHAIR |
Classification | Wheelchair, Standup |
Applicant | THE STANDING CO., INC. 1520 N. MICHIGAN Saginaw, MI 48602 |
Contact | David Maczik |
Correspondent | David Maczik THE STANDING CO., INC. 1520 N. MICHIGAN Saginaw, MI 48602 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-13 |
Decision Date | 1996-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B289SS1F0 | K962278 | 000 |
B289SS1 | K962278 | 000 |