510(k) K822022
- Device
- Sport Supports
- Applicant
- GINNY, INC.
- 510(k) number
- K822022
- Product code
- IQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-26
- Date received
- 1982-07-09
- Regulation
- 890.3475
- Classification name
- Orthosis, Limb Brace
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3009771224
- 3006089112
- 3009759525
- 1058152
- 1926174
- 3016598726
- 3030446844
- 3008754100
- 2245519
- 3014301596
- 3029785246
- 3043654665
- 3007774549
- 3008395114
- 3038636181
- 1721652
- 3011536935
- 3045853560
- 3030175335
- 3014060494
- 3009561590
- 3016000973
- 3016758972
- 1000649241
- 3025770454
- 2431499
- 3005539258
- 3007532528
- 3007222848
- 3011689956
- 3018609317
- 1421873
- 3010961310
- 3013950003
- 3013198248
- 1835998
- 3003981946
- 3015542783
- 3017619379
- 3026405350
- 9612388
- 3018117722
- 1016498
- 3005869201
- 3006400320
- 3010700223
- 3005103920
- 3033519
- 3043140679
- 3014663650
- 3007127133
- 3030180563
- 3012841710
- 3011363045
- 2321033
- 3008872348
- 3011678115
- 3008175569
- 3010097863
- 2529695
- 3010595915
- 3022418632
- 3014599232
- 3014943293
- 1057079
- 3009759417
- 3010508273
- 3005190268
- 3014847663
- 3045857302
- 1000626221
- 3021550083
- 3015142701
- 3005083016
- 3003855936
- 3009206505
- 3014690514
- 3020751373
- 3005533873
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143458 | Neurosplint | Neurospectrum, LLC | 2015-08-13 |
| K052771 | SENSOR WALK | Otto Bock Healthcare LP | 2006-05-03 |
| K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Surgitech, Inc. | 2003-07-31 |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| K910974 | MCCONNELL SHOULDER BRACE | Mcconnell Orthopedic | 1991-03-21 |
| K874502 | GAIT-AID ORTHOPEDIC INSOLE | Gait-Aid, Inc. | 1987-11-30 |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | 1983-06-24 |
| K831615 | DROP FOOT BRACE | Edward Dilauro, Jr. | 1983-06-15 |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | 1983-01-14 |
| K823113 | BRACE-UP ALL PURPOSE WRIST BAND | Arco Matic, Inc. | 1982-11-16 |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K823114 | BRACE-UP STOCKING KNEE BRACE | Arco Matic, Inc. | 1982-11-05 |
| K822767 | UNIVERSAL DYNASPLINT | Dynasplint Systems, Inc. | 1982-10-06 |
| K821704 | FRACTURE BRACING | Hosmer Dorrance Corp. | 1982-06-24 |
| K821640 | ORTHOTIC FABRICATION ACCESSORIES | Fred Sammons, Inc. | 1982-06-11 |