MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE

K963704 · Shippert Medical Technologies Corp. · LYG · Nov 26, 1996 · Physical Medicine

Device Facts

• Record ID: K963704
• Device Name: MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
• Applicant: Shippert Medical Technologies Corp.
• Product Code: LYG · Physical Medicine
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is used in the treatment and management of muscle spasm and muscle tension.

Device Story

Manual massage device; used for treatment/management of muscle spasm and tension. Features 'S' shape, roller beads, handles, interchangeable massage balls, and collapsible design. Operated by patient (OTC) or clinician. Applies mechanical pressure to anatomical sites to relieve muscle tension. Benefits include non-pharmacological management of muscle discomfort.

Clinical Evidence

No clinical data; device relies on established safety profile of predicate device sold OTC since 1990.

Technological Characteristics

Manual massage device; 'S' shape; includes roller beads, handles, and interchangeable massage balls; collapsible design. No energy source or software.

Indications for Use

Indicated for patients experiencing muscle spasm and/or muscle tension.

Regulatory Classification

Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

Predicate Devices

• Thera-Cane (K903820)

Submission Summary (Full Text)

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K963704
NOV 26 1996

# SECTION 14
## SMDA SUMMARY
### for Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92

# SAFETY AND EFFECTIVENESS OF THE MUSCLE WAND™

These proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Thera-Cane k903820 predicate device has a proven track record that establishes this product line as safe to the physical therapy patient. The modifications of design change of “S” shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.

The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated. Any modification made to the proposed device does not alter safety or effectiveness.

OTC Determination for this type of device has been proven safe to the consumer. The predicate device has been sold OTC since 1990 and has been proven to be an asset to the patient experiencing muscle spasm and/or muscle tension.

No claims are made implying cure. This device is used in the treatment and management of muscle spasm and muscle tension.

Sarah Maxwell Lake, Regulatory Affairs
Shippert Medical Technologies Corporation

September 9, 1996

filename: 510KWAND.doc

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