510(k) K963704
- Device
- MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
- Applicant
- SHIPPERT MEDICAL TECHNOLOGIES CORP.
- 510(k) number
- K963704
- Product code
- LYG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-26
- Date received
- 1996-09-16
- Regulation
- 890.5660
- Classification name
- Massager, Therapeutic, Manual
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SARAH MAXWELL LAKE
- Address
- 7002 S. Revere Pkwy. Suite 60 Englewood CO US 80112 80112
FDA Registration Numbers#
- 3005515252
- 3018981015
- 3018360321
- 3007238544
- 3015554544
- 3011564440
- 3007816986
- 3013557562
- 3021033518
- 3004126239
- 3015946389
- 3015217632
- 3007075140
- 3012360263
- 3025337862
- 3029952416
- 3017619615
- 3003755374
- 3005980667
- 3031583032
- 8022854
- 3027508655
- 3013285519
- 3019864920
- 3015972751
- 3010626066
- 3006223085
- 3017207289
- 3010027944
- 3008729549
- 3004526603
- 3008008970
- 3017618922
- 3025440611
- 3008103948
- 9617420
- 3033113207
- 3043750615
- 3043126945
- 3016879560
- 2939821
- 2032513
- 3012742764
- 3004264602
- 3015165898
- 3039435282
- 3030061860
- 3011205500
- 3043106344
- 3003175285
- 3007740394
- 3038369467
- 3021594345
- 3012381742
- 3014422258
- 3012025829
- 3012541016
- 3009273990
- 3005951403
- 3006537699
- 3017555752
- 3011630465
- 3007113238
- 3011150256
- 3033884638
- 3009759417
- 3013360665
- 3014159202
- 3030488262
- 1063974
- 3026818268
- 3018153150
- 3003539879
- 3005417950
- 3009068676
- 3015344405
- 3013180212
- 3007838093
- 3013627744
Source Documents#
Other 510(k) Records For Product Code LYG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K936312 | MANUAL MASSAGE ROLLER | Mckenna & Cuneo | 1996-01-29 |
| K952043 | BACK MASSAGER | Eight Corners, Inc. | 1995-09-01 |
| K930613 | HOOKING SYSTEM | Alain Machtelinckx | 1994-07-12 |
| K936148 | STRESS HANDLER | Arocep Enterprises , Ltd. | 1994-04-21 |
| K924315 | THE MASSAGER | Four Directions | 1993-10-08 |
| K922366 | SPINE LINE | Dambrecine, Inc. | 1992-07-13 |
| K915361 | THE BODY BUGGY | Innova Corp. | 1991-12-20 |
| K912512 | TAICHI STICK MASSAGER | Focus International, Inc. | 1991-09-06 |
| K903820 | THERA-CANE | Pro Message Co. | 1990-09-19 |
| K884907 | BUMPY MEDICAL MASSAGE MAT | Medical Flotation Systems, Inc. | 1988-12-27 |
| K881080 | DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER | Ferguson Medical | 1988-07-21 |
| K881081 | DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER | Ferguson Medical | 1988-07-21 |
Legacy Summary#
summary
FDA Review#
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