510(k) Report

510(k) · Cleared

Cleared

Reliefband NST Device, Model WB-2L, WB-6L, WB-RL

K994387510(k) TraditionalCleared Mar 16, 200079-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Woodside Biomedical, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Mar 16, 2000 as substantially equivalent to K982436 (Woodside Biomedical, Inc., 1998) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1997. 18 later devices descend from it.

Decided
Mar 16, 2000
Review
79 days
Class
Class II
Product code
GZJ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K961050 (1997). 4 ancestors in all. 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2004: 3 descendants cleared2002: 1 descendant cleared2018: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2006: 1 descendant cleared2021: 1 descendant cleared2016: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2007: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 1997K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 1998K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 19970
  1. Root · 3 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 2 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
  3. 1 generation backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  4. This deviceK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
  5. Descendant · cites it directly · 17 of its ownK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  6. Descendant · cites it directly · 10 of its ownK033268 Sea-BandSea-Band UK, Ltd. · 2004
  7. Descendant · 2 generations on · 7 of its ownK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
  8. Descendant · 2 generations on · 4 of its ownK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
  9. Descendant · 2 generations on · 3 of its ownK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002: 12004: 32005: 12006: 12007: 12011: 12012: 12014: 12016: 12018: 12020: 12021: 12022: 22023: 12025: 1
2002high 3 (2004) · low 0 (2003)2026

Most influential descendants

Showing 5 of 18 · See all
  • K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002 · cites it directly17descendants
  • K033268Sea-BandSea-Band UK, Ltd. · 2004 · cites it directly10descendants
  • K041877Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004 · 2 generations on7descendants
  • K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist StripTherapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011 · 2 generations on4descendants
  • K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist StripPressure Point, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961050Reliefband Tens Unit (Modification)Maven Labs, Inc.1997—
−2K980333ReliefbandWoodside Biomedical, Inc.1998—
−1K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc.1998—
0 (this device)K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000—
+1K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.2002—
+1K033268Sea-BandSea-Band UK, Ltd.2004—
+2K041877Acu-Strap Motion Sickness BandHealth Ent., Inc.2004—
+2K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management…Therapeutics 101, Inc (Dba Pressure Point, Inc.)2011—
+2K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist…Pressure Point, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200430
200510
200610
200710
201110
201210
201410
201610
201810
202010
202110
202220
202310
202510
FIG. 1 — Lineage of K994387, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GZJ device

  1. #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R
Summary page 1
…ssification: Class II D. Product Code: GZJ and BWK IDENTIFICATION OF PREDICATE DEVICE Device Manufacturer 510(k) No. Date Cleared ReliefBand, Woodside Biomedical, Inc. K982436 October 8, 1998 Models WB-2, K983907 December 9, 1999 WB-6, and WB-R 147 WOODSIDE BIOMEDICAL, INC. RelietBand™…
Woodside Biomedical, Inc.1998—
*K983907Reliefband NST Device Models WB-2,WB-6,WB-R
Summary page 1
…: GZJ and BWK IDENTIFICATION OF PREDICATE DEVICE Device Manufacturer 510(k) No. Date Cleared ReliefBand, Woodside Biomedical, Inc. K982436 October 8, 1998 Models WB-2, K983907 December 9, 1999 WB-6, and WB-R 147 WOODSIDE BIOMEDICAL, INC. RelietBand™ NST™ Model WB-xL Family Original Prem…
Woodside Biomedical, Inc.1999—

Also cleared against K982436: 1 other device →

What descends from it? (18)

See all 18

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.200217
K033268Sea-BandSea-Band UK, Ltd.200410

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 8 months on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K020180 (Woodside Biomedical, Inc., 2002) has gone furthest, with 17 descendants of its own.
  • 1 other device also cites its predicate K982436.

How does its category compare?

All GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZJ

1in 2025

2007: 132008: 112009: 162010: 52011: 52012: 122013: 22014: 42015: 32016: 32017: 32018: 22019: 32020: 42021: 32022: 42023: 12024: 32025: 12026 (partial year): 2
2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007: 223 days median2008: 136 days median2009: 155 days median2010: 232 days median2011: 168 days median2012: 154 days median2014: 344 days median2015: 202 days median2016: 163 days median2017: 113 days median2019: 156 days median2020: 183 days median2021: 231 days median2022: 175 days median2024: 207 days median
2007high 344 (2014) · low 113 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZJ

1in 2011

2007: 42008: 12011: 1
2007high 4 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZJ

13in 2025

2007: 42008: 452009: 172010: 222011: 222012: 202013: 102014: 232015: 182016: 322017: 582018: 212019: 72020: 102021: 52022: 42023: 392024: 122025: 13
2007high 58 (2017) · low 4 (2007)2025

MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071322344
200811136145
200916155017
20105232022
20115168122
201212154020
20132—010
20144344023
20153202018
20163163032
20173113058
20182—021
2019315607
20204183010
2021323105
2022417504
20231—039
20243207012
20251—013
20262—0—

What is it indicated for?

The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand ® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K982436

1 other device cites the same predicate.

  • K033268Sea-BandSea-Band UK, Ltd. · 2004

More from Woodside Biomedical, Inc.

6 FDA decisions under this applicant name. See the company

  • K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  • K983907Reliefband NST Device Models WB-2,WB-6,WB-RWoodside Biomedical, Inc. · 1999
  • K982967Reliefband MST Device, Models RB-2, RB-6, RB-RWoodside Biomedical, Inc. · 1999
  • K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  • K980333ReliefbandWoodside Biomedical, Inc. · 1998

Recent decisions in GZJ

The GZJ category page

  • K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
  • K252767actiTENS miniSublimed · 2026
  • K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
  • K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
  • K241228TENSWaveZynex Medical Officer · 2024

https://510kreport.com/device/K994387 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994387: Reliefband NST Device, Model WB-2L, WB-6L, WB-RL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994387

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026