The following data is part of a premarket notification filed by Alber Technologies, Inc. with the FDA for Power Wheelchair Conversion Kit.
Device ID | K943789 |
510k Number | K943789 |
Device Name: | POWER WHEELCHAIR CONVERSION KIT |
Classification | Wheelchair, Powered |
Applicant | ALBER TECHNOLOGIES, INC. C/O ARENT/FOX/KINTER/PLOT/KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
Contact | Mindy L Klasky |
Correspondent | Mindy L Klasky ALBER TECHNOLOGIES, INC. C/O ARENT/FOX/KINTER/PLOT/KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-03 |
Decision Date | 1994-11-08 |