The following data is part of a premarket notification filed by Theodore Barash with the FDA for Back In Action Compression & Support With Magnets For The Lower Back, Knee And Ankle.
| Device ID | K040054 |
| 510k Number | K040054 |
| Device Name: | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE |
| Classification | Bandage, Elastic |
| Applicant | THEODORE BARASH 16879 C ISLE OF PALMS DRIVE Delray Beach, FL 33484 |
| Contact | Theodore Barash |
| Correspondent | Theodore Barash THEODORE BARASH 16879 C ISLE OF PALMS DRIVE Delray Beach, FL 33484 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-04-27 |
| Summary: | summary |