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#
- 3030180563
- 3004727093
- 3004824601
- 3023212654
- 3008306818
- 3007392395
- 2183520
- 3008048783
- 1043533
- 3010220187
- 2087423
- 3005621301
- 1121034
- 1419520
- 3014527931
- 3013641287
- 3015277818
- 3010182295
- 1000626221
- 3007607706
- 9614756
- 3013783488
- 3013522894
- 1057404
- 8031020
- 3005846457
- 1812798
- 3042194079
- 3008175569
- 3033790380
- 3014476036
- 3016964847
- 3013195449
- 2529695
- 3007127133
- 2184046
- 3003890514
- 3010508273
- 3020282968
- 3030175335
- 3029702497
- 3027500264
- 3015142701
- 3013950003
- 3022418632
- 2530195
- 3010703418
- 3007731000
- 3040934694
- 3014209670
- 3010967704
- 3011706862
- 1062254
- 3016147813
- 3006240003
- 3005869201
- 3005951403
- 3006619688
- 3009240907
- 3016680721
- 2031823
- 1421873
- 3006085220
- 2134812
- 2183613
- 3008146511
- 3045030500
- 2183650
- 3013527364
- 9616933
- 3015942772
- 3012316249
- 3010158639
- 3006707030
- 3016172261
- 3003849847
- 3003855936
- 3003855981
- 3031572052
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 |