The following data is part of a premarket notification filed by Home Care Technology Co., Ltd. with the FDA for Home Care Various Models Of Powered Muscle Stimulator, Ht-326l.
| Device ID | K023001 |
| 510k Number | K023001 |
| Device Name: | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L |
| Classification | Stimulator, Muscle, Powered |
| Applicant | HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus, OH 43235 |
| Contact | Shu-chen Cheng |
| Correspondent | Shu-chen Cheng HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus, OH 43235 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2003-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873683215 | K023001 | 000 |