510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963704Substantially Equivalent

Muscle Wand, a Device for Deep Pressure Muscle Massage

Summit Medical, LLC, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963704 is the FDA 510(k) clearance record for MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE, a class I device, cleared for Shippert Medical Technologies Corp. on under FDA product code LYG (Massager, Therapeutic, Manual). FDA records list 27 510(k) clearances for SUMMIT MEDICAL LLC, from to . As of , FDA records show no recalls naming K963704.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LYG Massager, Therapeutic, Manual
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Shippert Medical Technologies Corp. 7002 S. Revere Pkwy., Englewood CO
510(k) summary
Summary
Third party review
No

Clearances, product code LYG

Trailing 12 months

FDA records hold no clearances under product code LYG in the trailing twelve months.

FDA records show no clearances under product code LYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260