510(k) K912512
- Device
- Taichi Stick Massager
- Applicant
- FOCUS INTERNATIONAL, INC.
- 510(k) number
- K912512
- Product code
- LYG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-06
- Date received
- 1991-06-06
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONY LAI
- Address
- 416 Hungerford Dr., Suite 204 Rockville MD US 20850 20850
FDA Registration Numbers#
- 3021033518
- 3016951909
- 3014159202
- 3020769982
- 3021594345
- 3015961134
- 3019783903
- 3007075140
- 3017555752
- 3008729549
- 3007238544
- 3032960769
- 3008103948
- 3010822231
- 3006897996
- 3030488262
- 3031583032
- 3005980667
- 3012110942
- 3012454655
- 3012025829
- 3015554544
- 3008346537
- 3012742764
- 3014982318
- 3016879560
- 3007113238
- 3006416350
- 3015214304
- 3007838093
- 3033113207
- 3010626066
- 3039346136
- 3005417950
- 3000335748
- 3013180212
- 8022854
- 3026818268
- 3016075803
- 3004126239
- 3030507585
- 3012184208
- 3007816986
- 3014314945
- 3004526603
- 3004839683
- 3008008970
- 8043323
- 3009759417
- 3043041482
- 3004039409
- 3003755374
- 3015217632
- 3005951403
- 3004112621
- 3013496867
- 3026322014
- 3025414368
- 3014326210
- 3043750615
- 3025235024
- 3019864920
- 3043106344
- 3011919098
- 3015499375
- 3018360321
- 3009746042
- 3027508655
- 1519375
- 3010883047
- 3004264602
- 3011150256
- 3011205500
- 3011839159
- 8022890
- 3027341447
- 3015176311
- 3008469990
- 3006610790
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Shippert Medical Technologies Corp. | 1996-11-26 |
| 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 |
| 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 |