Muscle Wand, a Device for Deep Pressure Muscle Massage
FDA 510(k) K963704 · Shippert Medical Technologies Corp.
510(k) numberK963704
Submission
- Device name
- Muscle Wand, a Device for Deep Pressure Muscle Massage
- Applicant
- Shippert Medical Technologies Corp.
Englewood, CO, US - Received
- September 16, 1996
- Decision date
- November 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYG – Massager, Therapeutic, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
Other 510(k)s with product code LYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K936312 | Manual Massage RollerLYG · Traditional | Mckenna & Cuneo | 01/29/1996SN |
| K952043 | Back MassagerLYG · Traditional | Eight Corners, Inc. | 09/01/1995SE |
| K930613 | Hooking SystemLYG · Traditional | Alain Machtelinckx | 07/12/1994SE |
| K936148 | Stress HandlerLYG · Traditional | Arocep Enterprises , Ltd. | 04/21/1994SN |
| K924315 | The MassagerLYG · Traditional | Four Directions | 10/08/1993SE |
| K922366 | Spine LineLYG · Traditional | Dambrecine, Inc. | 07/13/1992SE |
| K915361 | The Body BuggyLYG · Traditional | Innova Corp. | 12/20/1991SE |
| K912512 | Taichi Stick MassagerLYG · Traditional | Focus International, Inc. | 09/06/1991SE |
| K903820 | Thera-CaneLYG · Traditional | Pro Message Co. | 09/19/1990SE |
| K884907 | Bumpy Medical Massage MatLYG · Traditional | Medical Flotation Systems, Inc. | 12/27/1988SE |
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Questions and answers
When was Muscle Wand, a Device for Deep Pressure Muscle Massage cleared by the FDA?
Muscle Wand, a Device for Deep Pressure Muscle Massage (K963704) received a 510(k) decision of Substantially Equivalent on November 26, 1996, 71 days after the submission was received.
What is the product code of K963704?
The FDA product code is LYG – Massager, Therapeutic, Manual, a Class I (low risk) device regulated under 21 CFR 890.5660.