The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Muscle Wand, A Device For Deep Pressure Muscle Massage.
Device ID | K963704 |
510k Number | K963704 |
Device Name: | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE |
Classification | Massager, Therapeutic, Manual |
Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
Contact | Sarah Maxwell Lake |
Correspondent | Sarah Maxwell Lake SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
Product Code | LYG |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-16 |
Decision Date | 1996-11-26 |
Summary: | summary |