510(k) K101906
- Device
- SHAPE TO FIT COMPRESSION WEAR
- Applicant
- TSUNG HAU TECHNOLOGY CO., LTD.
- 510(k) number
- K101906
- Product code
- DWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-17
- Date received
- 2010-07-08
- Regulation
- 880.5780
- Classification name
- Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY KUO
- Address
- 3f, Bldg. A, #248-21, Sinsheng Rd., Taiwan, R.O.C. TW 806 KH 806 KH
FDA Registration Numbers#
- 1423537
- 3007942528
- 3013410562
- 2249769
- 1043551
- 3030630899
- 3009303371
- 3002960458
- 3007289408
- 3014150341
- 1038963
- 3016615875
- 3006227741
- 1511629
- 3008381219
- 3007123908
- 3023228837
- 1420054
- 8010507
- 1064876
- 3015134044
- 3009560029
- 3018267466
- 3006801236
- 2110898
- 3014646194
- 9614874
- 1450371
- 1928237
- 3043051412
- 3027495754
- 3007141284
- 3005037196
- 3017633586
- 3010398215
- 3011714258
- 3010453133
- 9616933
- 3016659819
- 1921846
- 9616086
- 1043537
- 3008973893
- 3009394814
- 3005121802
- 3010920695
- 3012465068
- 8043565
- 3011556461
- 3043226252
- 3005273623
- 3005012805
- 3015199390
- 3012251300
- 1043644
- 3003902312
- 1000649241
- 3007084481
- 1422443
- 3016904853
- 3006943846
- 3014144875
- 9611956
- 3009541440
- 3009211636
- 3017264244
- 3009993798
- 1417592
- 8010822
- 3033436414
- 3023344926
- 3015058854
- 3030220356
- 3006973677
- 3035597675
- 1057079
- 3011191255
- 3016761372
- 3012494290
Source Documents#
Other 510(k) Records For Product Code DWL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141127 | MEDLINE ANTI-EMBOLISM STOCKING | Medline Industries, Inc. | 2014-08-21 |
| K131496 | BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) | Bsn Medical, Inc. | 2013-07-10 |
| K122485 | ENCIRCLE COMPRESSION THERAPY STOCKING | Encircle Medical Devices , Ltd. | 2013-04-23 |
| K123820 | BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS | Bossong Hosiery Mills, Inc. | 2013-04-02 |
| K123085 | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | 3M Company | 2012-12-20 |
| K123561 | ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS | Bsn Medical, Inc. | 2012-12-18 |
| K123398 | DR. SCHOLL'S COMPRESSION SOCKS | Renfro Corporation | 2012-12-18 |
| K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | Surgical Appliance Industries, Inc. | 2012-04-27 |
| K112769 | CURAD COMPRESSION HOSIERY | Medline Industries, Inc. | 2012-03-01 |
| K111662 | VENOTRAIN CURAFLOW | Bauerfeind AG | 2011-10-04 |
| K101614 | HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 | Dm Systems, Incorporated | 2011-01-13 |
| K101224 | SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS | Griffiths and Nielsen, Ltd. | 2010-12-03 |
| K092892 | 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 | I-Ming Sanitary Materials Co., Ltd. | 2010-08-03 |
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Beiersdorf, Inc. | 2009-12-18 |
| K091141 | THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS | Knit-Rite, Inc. | 2009-07-24 |
Legacy Summary#
summary
FDA Review#
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