The following data is part of a premarket notification filed by Pain Management Technologies, Inc. with the FDA for Armory Motion.
Device ID | K213097 |
510k Number | K213097 |
Device Name: | Armory Motion |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | Pain Management Technologies, Inc. 1760 Wadsworth Rd. Akron, OH 44320 |
Contact | Joshua A. Lefkovitz |
Correspondent | Joshua A. Lefkovitz Pain Management Technologies, Inc. 1760 Wadsworth Rd. Akron, OH 44320 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-24 |
Decision Date | 2022-06-10 |