SIA TONUS ELAST / TONUS ELAST LLC.

FDA Device Registration & Listing · Grinvalti,Nicas pag Nicas Novads, LV · Registration 3011240418

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011240418
FEI Number
3011240418
Entity Name
SIA TONUS ELAST / TONUS ELAST LLC.
City/State/Country
Grinvalti,Nicas pag Nicas Novads, LV
Establishment Address
Dienvidkurzemes nov, Pilskalni, Grinvalti,Nicas pag Nicas Novads LV-3473, LV
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SIA Tonus Elast /Tonus Elast, LLC. (Owner Number: 10057284)
Owner / Operator Contact Address
Dienvidkurzemes nov, Pilskalni, Grinvalti, Nicas pag, LV-NOTA LV-3473, LV
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ELAST 9901 AIR Neoprene medical elastic bandage for splinting of the finger of the hand, with a rigid insert (Finger Splint) Tennis Elbow Splint (Elbow Splint) ELAST 0001 ELAST 9901 Comfort TONUS 0511-01 Elastic medical belt for umbilical hernia treatment TONUS 0511 Elastic medical belt for inguinal hernia treatment TONUS 0511D-01 Elastic medical belt for umbilical hernia ELAST 0211 LUX ELAST 0110 Medical elastic orthopedic arm support. ELAST 9605 TONUS 0012 Elastic medical belt TONUS 0012 Medical elastic lumbar fixation corset. ELAST 0008 Irena Elastic medical maternity belt, with cotton TONUS 9909-01 Medical elastic neoprene lumbar fixation corset. ELAST 9806 Gerda Elastic medical maternity belt, universal TONUS 0012-02 AIR Medical elastic lumbar fixation corset from breathable and durable material with metal inserts and TONUS 0012-01 Medical elastic lumbar fixation corset with stiff inserts and straps for regulating compression TONUS 9509-01 Warming medical elastic lumbar bandage ELAST 0009 Kira Comfort Elastic medical maternity belt, with advanced back support ELAST 9806 Gerda LUX Elastic medical maternity belt, with extra soft inner layer TONUS 0312 Medical elastic neoprene lumbar fixation corset with straps for regulating compression. TONUS 9509-AM Warming medical elastic lumbar bandage with angora and merino wool. TONUS 9509 Warming medical elastic lumbar bandage TONUS 0012-01 AIR Medical elastic lumbar fixation corset from breathable and durable material TONUS 0012-01 LUX Medical elastic lumbar fixation corset with metal inserts and removable straps for regulating compress with metal inserts and straps for regulating compression, reinforced TONUS0012-01Comfort Medical elastic lumbar fixatio corsetwith metal insertsandstraps for regulating compressionreinforce straps for regulating compression, reinforced ELAST 9806 Gerda AIR Elastic medical maternity belt, made of wear-resistant breathable material ELAST 0107 Comfort ELAST 0108-01 AIR ELAST 0107 AIR ELAST 0108 Comfort ELAST 0401 LUX 2 – Medical compression knee-high stockings, unisex ELAST 0403 LUX 2 – Medical compression thigh-high stockings without toe, unisex ELAST 0408 LUX 2 – Medical compression knee-high stockings without toe, unisex Articles ELAST 469 Medical compression tights Articles ELAST 0401 Soft Elastic medical compression knee stockings with toecap ,unisex Articles TONUS 0403 LUX Elastic medical compression arm sleeve Articles ELAST 0401 Cotton Elastic medical compression knee stockings with toecap, with cotton, unisex Articles ELAST 0402 LUX Elastic medical compression thigh stockings with toecap, unisex Articles ELAST 0401 TRAVEL Elastic medical compression long socks, with toecap Articles ELAST 0403 Hospital Elastic medical compression thigh stockings with inspection opening, anti embolism, unisex Articles ELAST 0408 LUX Elastic medical compression knee stockings without toecap, unisex Articles ELAST 0408 Elastic medical compression knee stockings without toecap, unisex Articles ELAST 0401 LUX Elastic medical compression knee stockings with toecap, unisex Articles ELAST 0404 Elastic medical compression tights Articles ELAST 0404 LUX MAX Elastic medical compression tights for larger hip sizes Articles ELAST 0404 LUX Elastic medical compression tights ;Articles ELAST 0403 LUX Elastic medical compression thigh stockings without toecap, unisex Articles ELAST 0402 Soft Elastic medical compression thigh stockings with toecap, unisex Articles ELAST 0402 Elastic medical compression thigh stockings with toecap, unisex Articles ELAST 0402 DR Elastic medical compression thigh stockings, patterned, with toecap Articles ELAST 0403-01 LUX Elastic medical compression mono-stockings without toecap, with fastener on the waistline, unisex Articles ELAST 0408 Hospital Medical compressive long socks without toecap, unisex, anti-embolic Articles TONUS 0403-01 LUX Elastic medical compression arm sleeve with shoulder strap Articles ELAST 0401 Active Elastic compression knee stockings for active lifestyle, unisex Articles ELAST 0405 LUX Medical elastic compression tights for pregnant women Articles ELAST 0403-01 Hospital Elastic medical compression mono-stocking with inspection opening Articles ELAST 0404 Soft Elastic medical compression tights Articles ELAST 0408 01 Active Elastic compression calf sleeves active lifestyle, unisex Articles ELAST 0408 02 Active Elastic compression calf sleeves active lifestyle, with foot straps, unisex Articles ELAST 0404 DR Elastic medical compression tights, patterned Articles ELAST 0401 Elastic medical compression knee stockings with toecap, unisex Articles ELAST 0402 LUX MAX Elastic medical compression thigh stockings for larger thigh sizes Articles TONUS 0403-02 LUX Elastic medical compression arm sleeve with shoulder strap and gauntlet Articles ELAST 0401 Business Elastic medical compression knee stockings, with pattern, with toecap Articles ELAST 0402 LUX DR Elastic medical compression thigh stockings, patterned, with toecap Articles ELAST 0404 LUX DR Elastic medical compression tights, patterned ELAST 0403 Active Elastic compression thigh stockings for active lifestyle, unisex ELAST 0403 Soft Elastic medical compression thigh stockings without toecap, unisex Model No. – 0401 3Hearts ELAST 0408 Soft Elastic medical compression knee stockings without toecap, unisex ELAST 0402 3Hearts 0401 Casual -Medical elastic compression knee-high stockings, closed toe, Class I compression ELAST 0402 LUX 2 – Medical compression thigh-high stockings, unisex Application FDA _listing_2021_06_TE_prod)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2026-04-03
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2021-06-22
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2018-03-15
EXN Support, Hernia Gastroenterology, Urology Class 1 876.5970 2018-03-16
IOY Support, Arm Physical Medicine Class 1 890.3475 2026-04-03
FQM Bandage, Elastic General Hospital Class 1 880.5075 2026-04-03
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2018-03-16
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2018-03-16
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2018-05-09
FQJ Support, Scrotal, Therapeutic General Hospital Class 1 880.5820 2021-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SIA Tonus Elast /Tonus Elast, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011240418. Last updated year: 2026. Please use registration number 3011240418 when referencing this establishment in official correspondence.
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