The following data is part of a premarket notification filed by Portable Therapeutix, Llc with the FDA for Portable Therapeutix Squid Active Cold Compression Device And Cold Pack.
| Device ID | K123829 |
| 510k Number | K123829 |
| Device Name: | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | PORTABLE THERAPEUTIX, LLC 200 HOMER AVE. Ashland, MA 01721 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton PORTABLE THERAPEUTIX, LLC 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-04-03 |
| Summary: | summary |