Stocking, Medical Support (for General Medical Purposes)
General Hospital · 21 CFR 880.5780
Recent MDR events
24 adverse event reports on file
- JUZO COMPRESSION PANTYHOSEAug 14, 2025InjuryJulius Zorn, Inc.MW5174541
- SIGVARIS COMPRESSION PANTYHOSEAug 14, 2025InjurySigvaris, Inc.MW5174542
- WEMMay 23, 2025MalfunctionCovidien Mfg Dc Boulder1717344-2025-00671
- SOOTHRELIEVEApr 29, 2025MalfunctionUnknownMW5169628
- THERAPEUTIC MOISTURIZING SOCKS GEL LINEDSep 17, 2024OtherUnknownMW5159711
- ALBA HEALTHJan 30, 2023MalfunctionAlba Health3014527682-2023-00001
- MEDLINE XL PATIENT SOCKAug 18, 2022InjuryMedline Industruies15248848
- JUZO DYNAMIC COMPRESSION STOCKING, OPEN TOE 3511 TYPE AD SIZE IV 5CMSILICONEAug 17, 2022InjuryJulius Zorn, Inc.MW5111561
- ASTRAL 100 - EUR4Feb 25, 2022MalfunctionResmed Ltd3007573469-2022-00118
- 20-30 SURG THCT BANDNov 13, 2019InjuryDjo, Llc3004116007-2019-00001
Event type breakdown
Recalls
2 recall events for this product code
- Surgical Appliance IndustriesTerminatedJan 11, 2012
Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of
During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
Z-0391-2012 · View FDA record ↗ - Surgical Appliance IndustriesTerminatedJan 11, 2012
Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209
During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
Z-0392-2012 · View FDA record ↗
Registered firms
272 firms currently registered for this product code
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Total Vein Systems
Houston, TX, US
Pantymed S.a.
BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
Anji Spenq Industrial Co., Ltd.
Huzhou Zhejiang, CN
Haddenham Healthcare Ltd
Long Crendon Buckinghamshire, GB
Suzhou Acmed Import & Export Co., Ltd.
SUZHOU Jiangsu, CN
Core Products Intl., Inc.
OSCEOLA, WI, US
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Viecura Medical Textiles Company Limited
Samrong Takeo, KH
Isomedix Operations, Inc.
Libertyville, IL, US
Joyles Textiles Technology Ltd.
Yiwu Zhejiang, CN
Medi Usa, Lp
WHITSETT, NC, US
Julius Zorn Gmbh
AICHACH Bavaria, DE
Sigvaris Do Brasil Ind. E Com. Ltda
Jundiai Sao Paulo, BR
Djo, Llc
Carlsbad, CA, US
Amerx Healthcare Corp
Oldsmar, FL, US
Double Care Medical Technology Co.,ltd.
Liwu Shiwan Boluo Guangdong, CN
Thuasne, Llc
BAKERSFIELD, CA, US
Welltex Sports Co., Ltd.
Taipei City, TW
Hongyu Biotech (shenzhen) Co., Ltd.
Shenzhen Guangdong, CN
Elidah
Newtown, CT, US
Walt Technology Group Co., Ltd.
Haining Zhejiang, CN
Ningbo Unico Products Co., Ltd
Ningbo Zhejiang, CN
Vernon Area Rehabilitation Center, Inc. - Sauk Division
Reedsburg, WI, US
Ningbo Favored Commodity Co.,ltd
NINGBO Zhejiang, CN
510(k) clearances
6 clearances for this product code
- Silipos, Inc.Dec 27, 1994
K944240 · SOFT SOCK
- Orthopaedic Resources Corp.Jan 7, 1983
K823789 · ELASTIC COMPRESSION ANKLET
- Podiatry Products Corp.Dec 3, 1982
K823350 · ELASTIC COMPRESSION ANKLET
- Selomas, Inc.Jun 23, 1982
K821259 · VITASAN
- Selomas, Inc.Jun 23, 1982
K821260 · VITOFIT
- Jung Products, Inc.Mar 18, 1982
K820484 · VENES CUSTON RX