The following data is part of a premarket notification filed by Axiobionics Llc with the FDA for Wearable Therapy Garments.
| Device ID | K141342 |
| 510k Number | K141342 |
| Device Name: | WEARABLE THERAPY GARMENTS |
| Classification | Electrode, Cutaneous |
| Applicant | AXIOBIONICS LLC PO BOX 506 South Lyon, MI 48178 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard AXIOBIONICS LLC PO BOX 506 South Lyon, MI 48178 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3673350 | K141342 | 000 |
| B367118P20 | K141342 | 000 |
| B367119P20 | K141342 | 000 |
| B367120P20 | K141342 | 000 |
| B367121P20 | K141342 | 000 |
| B367122P20 | K141342 | 000 |
| B367123P20 | K141342 | 000 |
| B367124P20 | K141342 | 000 |
| B367125P20 | K141342 | 000 |
| B367126P20 | K141342 | 000 |
| B367127P20 | K141342 | 000 |
| B367128P20 | K141342 | 000 |
| B367117P20 | K141342 | 000 |
| B367116P20 | K141342 | 000 |
| B367115P20 | K141342 | 000 |
| B3670030 | K141342 | 000 |
| B3670040 | K141342 | 000 |
| B3670100 | K141342 | 000 |
| B3670210 | K141342 | 000 |
| B3670320 | K141342 | 000 |
| B3670440 | K141342 | 000 |
| B3670530 | K141342 | 000 |
| B3670610 | K141342 | 000 |
| B3670700 | K141342 | 000 |
| B367080 | K141342 | 000 |
| B367100M00 | K141342 | 000 |
| B367130P20 | K141342 | 000 |
| B367133P20 | K141342 | 000 |
| B3676300 | K141342 | 000 |
| B3676400 | K141342 | 000 |
| B3676500 | K141342 | 000 |
| B3676600 | K141342 | 000 |
| B3676700 | K141342 | 000 |
| B3676800 | K141342 | 000 |
| B3676970 | K141342 | 000 |
| B3676980 | K141342 | 000 |
| B3677010 | K141342 | 000 |
| B3677110 | K141342 | 000 |
| B3677200 | K141342 | 000 |
| B3676210 | K141342 | 000 |
| B3676100 | K141342 | 000 |
| B3676000 | K141342 | 000 |
| B367134P20 | K141342 | 000 |
| B367135P20 | K141342 | 000 |
| B367136P20 | K141342 | 000 |
| B3673010 | K141342 | 000 |
| B3673140 | K141342 | 000 |
| B3673240 | K141342 | 000 |
| B3673340 | K141342 | 000 |
| B3673440 | K141342 | 000 |
| B3673500 | K141342 | 000 |
| B367360 | K141342 | 000 |
| B3673600 | K141342 | 000 |
| B3677370 | K141342 | 000 |