510(k) K813632
- Device
- Color Coded Weight Cuffs
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K813632
- Product code
- IOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-01-19
- Date received
- 1981-12-29
- Regulation
- 890.5350
- Classification name
- Components, Exercise
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005497907
- 3015173212
- 3031231834
- 3014159202
- 3005673742
- 3009495988
- 3014101700
- 3015468814
- 3007076137
- 2031918
- 3027500264
- 3031583032
- 3015554544
- 3009265647
- 3032847788
- 2028253
- 3004967086
- 3010694026
- 3007218972
- 1026765
- 3015287620
- 2531778
- 3007889024
- 3013180212
- 3013019728
- 9617759
- 3010309201
- 3004526603
- 8040255
- 2432177
- 3009759417
- 1218386
- 3013021200
- 3007280950
- 9616086
- 3011659880
- 3006400320
- 2242467
- 3021815
- 3010171505
- 1519375
- 3008603863
- 3009240152
- 3006537699
- 3012251300
- 3010595915
- 3010133264
- 3013875684
- 3008936260
- 2183988
- 3004905643
- 1530951
- 1422443
- 3009142693
- 3038636181
- 9611956
- 3038610665
- 1424774
- 3003520997
- 3017264244
- 1523547
- 1417592
- 2131610
- 2431497
- 3012579728
- 3008997160
- 3009134760
- 3007145088
- 3007392395
- 3011191255
- 3020282968
- 3004824601
- 9611742
- 3003890514
- 3009425025
- 3010664759
- 3001452523
- 3033571806
- 2939821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Fred Sammons, Inc. | 1983-06-24 |
| K823648 | SURGICAL TUBING | Fred Sammons, Inc. | 1983-01-21 |
| K823822 | ANKLE WEIGHTS | Danek Medical, Inc. | 1983-01-14 |
| K823600 | SOLID WOOD CONE | Fred Sammons, Inc. | 1982-12-22 |
| K812319 | THERAPY BENCH | Kaye Products, Inc. | 1981-08-31 |
| K790587 | CANVAS WEDGE | Maddak, Inc. | 1979-04-03 |
| K772414 | SANDBAGS, VARIOUS WEIGHTS | Fred Sammons, Inc. | 1978-02-01 |
| K771030 | FLEXION MITTENS | Stat Medical Corp. | 1977-06-27 |
| K761118 | HAND SCREW CLAMP | Fred Sammons, Inc. | 1976-12-02 |
| K761119 | SHEET METAL CLAMP | Fred Sammons, Inc. | 1976-12-02 |