The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Models 4100 And 4300 Multitherapy.
Device ID | K945954 |
510k Number | K945954 |
Device Name: | MODELS 4100 AND 4300 MULTITHERAPY |
Classification | Table, Physical Therapy, Multi Function |
Applicant | SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
Contact | T A Cox |
Correspondent | T A Cox SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-06 |
Decision Date | 1995-01-19 |